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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

Anastrazole and Clomiphene to Evaluate Hypogonadal Symptoms and Erectile Function

Clinicaltrials.gov identifier NCT03933618

Recruitment Status Completed

First Posted May 1, 2019

Result First Posted November 18, 2019

Last update posted November 18, 2019

Study Description

Brief summary:

This study evaluates anastrazole and clomiphene in the improvement in hypogonadal symptoms and erectile function. Each subject will receive Anastrazole 1 mg/day, clomiphene 25 mg/day and placebo in randomized schedule of 8 week intervals.

  • Condition or Disease:Hypogonadism, Male
  • Intervention/Treatment: Drug: Anastrozole 1mg
    Drug: Clomiphene Citrate 25mg
    Drug: Placebo - Cap
  • Phase: Phase 2
Detailed Description

Aromatase inhibitors (AI) (Anastrazole) and selective estrogen receptor modifiers (SERMS)(clomiphene) increase testosterone production through stimulation of the hypothalamic pituitary axis. While these drugs both reduce the feedback inhibition of estrogen on the pituitary, SERMs cause an increase in serum estradiol, whereas AIs reduce estradiol levels. Using these medications, we can obtain therapeutic testosterone levels with either an increase or decrease in estradiol levels.

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 24 participants
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Masking: Triple (Participant, Care Provider, Investigator)
  • Primary Purpose: Treatment
  • Official Title: A Randomized Double Blinded Placebo Controlled Trial Between Anastrozole and Clomiphene to Evaluate Improvement in Hypogonadal Symptoms and Erectile Function Using ADAM, IIEF and EHS Validated Scales
  • Actual Study Start Date: April 2015
  • Actual Primary Completion Date: March 2017
  • Actual Study Completion Date: March 2017
Arms and interventions
Arm Intervention/treatment
Other: anastrazole-clomiphene-placebo
anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks
Drug: Anastrozole 1mg


Drug: Clomiphene Citrate 25mg


Drug: Placebo - Cap
Other: anastrazole-placebo-clomiphene
anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks
Drug: Anastrozole 1mg


Drug: Clomiphene Citrate 25mg


Drug: Placebo - Cap
Other: clomiphene-anastrazole-placebo
clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks
Drug: Anastrozole 1mg


Drug: Clomiphene Citrate 25mg


Drug: Placebo - Cap
Other: clomiphene-placebo-anastrazole
clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks
Drug: Anastrozole 1mg


Drug: Clomiphene Citrate 25mg


Drug: Placebo - Cap
Other: placebo-anastrazole-clomiphene
placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks
Drug: Anastrozole 1mg


Drug: Clomiphene Citrate 25mg


Drug: Placebo - Cap
Other: placebo-clomiphene-anastrazole
placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks
Drug: Anastrozole 1mg


Drug: Clomiphene Citrate 25mg


Drug: Placebo - Cap
Outcome Measures
  • Primary Outcome Measures: 1. IIEF (International Index of Erectile Function) Score - Screen [ Time Frame: At baseline ]
    15 item self reported erectile function. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75
  • 2. IIEF (International Index of Erectile Function) Score - Week 8 [ Time Frame: Week 8 ]
    15 item self reported erectile function over the past 8 weeks. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75
  • 3. IIEF (International Index of Erectile Function) Score - Week 16 [ Time Frame: Week 16 ]
    15 item self reported erectile function over the past 8 weeks. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75
  • 4. IIEF (International Index of Erectile Function) Score - Week 24 [ Time Frame: Week 24 ]
    15 item self reported erectile function over the past 8 weeks. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75
  • Secondary Outcome Measures: 1. SHBG - Week 8 [ Time Frame: Week 8 ]
    Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24
  • 2. Normalized Testosterone - Screen [ Time Frame: Baseline ]
    Normalized at >350ng/dl
  • 3. Normalized Testosterone - Week 8 [ Time Frame: Week 8 ]
    Normalized at >350ng/dl
  • 4. Normalized Testosterone - Week 16 [ Time Frame: Week 16 ]
    Normalized at >350ng/dl
  • 5. Normalized Testosterone - Week 24 [ Time Frame: Week 24 ]
    Normalized at >350ng/dl
  • 6. ADAM (Androgen Deficiency in the Aging Male) Score - Screen [ Time Frame: Baseline ]
    Self reported quantification of hypogonadism. 10 "yes" or "no" questions. A positive (yes) questionnaire result is defined as a "yes or 1" and a negative (no) questionnaire result is defined as a "no or 0" to question 1 or question 7 or any 3 other questions. Yes (1) represents a better outcome than No (1) In Data Entry: Yes - 1 No - 0
  • 7. ADAM (Androgen Deficiency in the Aging Male) Score - Week 8 [ Time Frame: Week 8 ]
    Self reported quantification of hypogonadism. 10 "yes" or "no" questions. A positive (yes) questionnaire result is defined as a "yes or 1" and a negative (no) questionnaire result is defined as a "no or 0" to question 1 or question 7 or any 3 other questions. Yes (1) represents a better outcome than No (1) In Data Entry: Yes - 1 No - 0
  • 8. ADAM (Androgen Deficiency in the Aging Male) Score - Week 16 [ Time Frame: Week 16 ]
    Self reported quantification of hypogonadism. 10 "yes" or "no" questions. A positive (yes) questionnaire result is defined as a "yes or 1" and a negative (no) questionnaire result is defined as a "no or 0" to question 1 or question 7 or any 3 other questions. Yes (1) represents a better outcome than No (1) In Data Entry: Yes - 1 No - 0
  • 9. ADAM (Androgen Deficiency in the Aging Male) Score - Week 24 [ Time Frame: Week 24 ]
    Self reported quantification of hypogonadism. 10 "yes" or "no" questions. A positive (yes) questionnaire result is defined as a "yes or 1" and a negative (no) questionnaire result is defined as a "no or 0" to question 1 or question 7 or any 3 other questions. Yes (1) represents a better outcome than No (1) In Data Entry: Yes - 1 No - 0
  • 10. EHS (Erectile Hardness Score) - Screen [ Time Frame: Baseline ]
    Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid
  • 11. EHS (Erectile Hardness Score) - Week 8 [ Time Frame: Week 8 ]
    Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid
  • 12. EHS (Erectile Hardness Score) - Week 16 [ Time Frame: Week 16 ]
    Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid
  • 13. EHS (Erectile Hardness Score) - Week 24 [ Time Frame: Week 24 ]
    Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid
  • 14. LH - Screen [ Time Frame: Baseline ]
    Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods.
  • 15. LH - Week 8 [ Time Frame: Week 8 ]
    Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods.
  • 16. LH - Week 16 [ Time Frame: Week 16 ]
    Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods.
  • 17. LH - Week 24 [ Time Frame: Week 24 ]
    Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods.
  • 18. FSH - Screen [ Time Frame: Baseline ]
    Lab Values for follicle stimulating hormone
  • 19. FSH - Week 8 [ Time Frame: Week 8 ]
    Lab Values for follicle stimulating hormone
  • 20. FSH - Week 16 [ Time Frame: Week 16 ]
    Lab Values for follicle stimulating hormone
  • 21. FSH - Week 24 [ Time Frame: Week 24 ]
    Lab Values for follicle stimulating hormone
  • 22. Free Testosterone - Screen [ Time Frame: Baseline ]
    Measure of Free Testosterone
  • 23. Free Testosterone - Week 8 [ Time Frame: Week 8 ]
    Measure of Free Testosterone
  • 24. Free Testosterone - Week 16 [ Time Frame: Week 16 ]
    Measure of Free Testosterone
  • 25. Free Testosterone - Week 24 [ Time Frame: Week 24 ]
    Measure of Free Testosterone
  • 26. Estradiol - Screen [ Time Frame: Baseline ]
    Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24
  • 27. Estradiol - Week 8 [ Time Frame: Week 8 ]
    Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24 An entered value of 4.9 means the measure was <5
  • 28. Estradiol - Week 16 [ Time Frame: Week 16 ]
    Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24 An entered value of 4.9 means the measure was <5
  • 29. Estradiol - Week 24 [ Time Frame: Week 24 ]
    Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24 An entered value of 4.9 means the measure was <5
  • 30. SHBG - Screen [ Time Frame: Baseline ]
    Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24
  • 31. SHBG - Week 16 [ Time Frame: Week 16 ]
    Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24
  • 32. SHBG - Week 24 [ Time Frame: Week 24 ]
    Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24
  • 33. SEP #1-3 Cumulative - Screen [ Time Frame: Baseline ]
    Questions 1, 2, and 3 for the Sexual Encounter Profile have been cumulatively added. 1 - yes and 0 - no have been added for questions 1-3 to determine a total value from 0-3. 0-3: cumulative score from SEP questions 1, 2, and 3 Higher values (3) are considered to be a better outcomes relative to lower numbers (0) 3 is better than 2 is better than 1 is better than 0
  • 34. SEP #1-3 Cumulative - Week 8 [ Time Frame: Week 8 ]
    Questions 1, 2, and 3 for the Sexual Encounter Profile have been cumulatively added. 1 - yes and 0 - no have been added for questions 1-3 to determine a total value from 0-3. 0-3: cumulative score from SEP questions 1, 2, and 3 Higher values (3) are considered to be a better outcomes relative to lower numbers (0) 3 is better than 2 is better than 1 is better than 0
  • 35. SEP #1-3 Cumulative - Week 16 [ Time Frame: Week 16 ]
    Questions 1, 2, and 3 for the Sexual Encounter Profile have been cumulatively added. 1 - yes and 0 - no have been added for questions 1-3 to determine a total value from 0-3. 0-3: cumulative score from SEP questions 1, 2, and 3 Higher values (3) are considered to be a better outcomes relative to lower numbers (0) 3 is better than 2 is better than 1 is better than 0
  • 36. SEP #1-3 Cumulative - Week 24 [ Time Frame: Week 24 ]
    Questions 1, 2, and 3 for the Sexual Encounter Profile have been cumulatively added. 1 - yes and 0 - no have been added for questions 1-3 to determine a total value from 0-3. 0-3: cumulative score from SEP questions 1, 2, and 3 Higher values (3) are considered to be a better outcomes relative to lower numbers (0) 3 is better than 2 is better than 1 is better than 0
Eligibility Criteria
  • Ages Eligible for Study: 18 to 70 Years (Adult, Older Adult)
  • Sexes Eligible for Study: Male
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

1. Men age 18-70

2. Baseline morning Testosterone 150-350 ng/dL x2

3. leutenizing hormone (LH) 1.5-9.2 miU/mL, Follicle stimulation hormone (FSH) 1.6-8.0
miU/mL, Prolactin 4-15 ng/mL

4. Positive Androgen Deficiency in the Aging Male (ADAM) score. A positive score is when
an affirmative answer (''yes'') to either questions "Do you have a decreased sex
drive/libido?" or "Are your erections less strong?" or any three other questions.10

5. Body mass index (BMI) 7 and 30 grams (drink more than 2 beers per day OR more than 1 glass of
wine or cocktail daily)

13. Having started a new medication during the past three months which may interfere with
the outcome measures of the study

14. Polycythemia (HCT >52% )

15. History of prostate specific antigen (PSA)> 4.0 ng/dl

16. Hematocrit (HCT)< 36 % 17. Liver function tests greater than 2 times upper normal limits or history of abnormal electrolytes, calcium or Parathyroid hormone without workup, at the discretion of the investigator. 18. Previous hypogonadal treatment within last 3 months. -

Contacts and Locations
Contacts
Locations
Sponsors and Collaborators

Albany Medical College

Laboratory Corporation of America

Investigators

Principal Investigator: Robert C Welliver, MD Albany Medical College

More Information
  • Responsible Party: Albany Medical College
  • ClinicalTrials.gov Identifier: NCT03933618 History of Changes
  • Other Study ID Numbers: 4134
  • First Posted: May 1, 2019 Key Record Dates
  • Last Update Posted: November 18, 2019
  • Last Verified: October 2019
  • Product Manufactured in and Exported from the U.S.: Yes
  • Additional relevant MeSH terms: Eunuchism Hypogonadism
  • Study Type: Interventional
  • Study Design: Allocation: Randomized;Intervention Model: Crossover Assignment;Masking: Triple;Primary Purpose: Treatment
  • Condition: Hypogonadism, Male
  • Interventions : Drug: Anastrozole 1mg
    Drug: Clomiphene Citrate 25mg
    Drug: Placebo - Cap
  • Enrollment: 24
Participant flow
Recruitment Details Men will be incentivized to come to each clinic appointment with $20 dollars at the end. If they complete the study they will be able to earn $100. Men will be incentivized to not use phosphodiesterase inhibitors throughout the study by giving them three 100mg tablets of Viagra per month of the study for a total of twelve 100 mg tablets.
Pre-assignment Details
Arm/Group title Placebo-anastrazole-clomiphene Placebo-clomiphene-anastrazole Clomiphene-placebo-anastrazole Clomiphene-anastrazole-placebo Anastrazole-placebo-clomiphene Anastrazole-clomiphene-placebo
Arm/Group Description placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
Period Title: Week 16 to Week 24
Started 4 4 4 4 4 4
Completed 4 4 4 4 4 4
Not Completed 0 0 0 0 0 0
Reason Not Completed
Period Title: Week 8 to Week 16
Period Title: Baseline to Week 8
Period Title: Baseline
Baseline Characteristics
Arm/Group title TotalPlacebo-anastrazole-clomiphenePlacebo-clomiphene-anastrazoleClomiphene-placebo-anastrazoleClomiphene-anastrazole-placeboAnastrazole-placebo-clomipheneAnastrazole-clomiphene-placebo
Arm/Group Description Total of all reporting groupsplacebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capplacebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
Overall Number of Baseline Participants 24444444
Baseline Analysis Population Description [Not Specified]
Region of Enrollment Measure Type: Number Unit of Measure: Participants Number Analyzed 24 Participants4 Participants4 Participants4 Participants4 Participants4 Participants4 Participants
Outcome Measures
1. PrimaryOutcome
Title IIEF (International Index of Erectile Function) Score - Week 24
Description 15 item self reported erectile function over the past 8 weeks. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75
Time Frame Week 24
Outcome Measure Data
Analysis Population Description
Total IIEF reported at the end of the final 8 week period - at week 24 Data was not collected for patient 15 in clomiphene-anastrazole-placebo arm Data was not collected for patient 23 in placebo-clomiphene-anastrazole
 
Arm/Group title Placebo-anastrazole-clomiphenePlacebo-clomiphene-anastrazoleClomiphene-placebo-anastrazoleClomiphene-anastrazole-placeboAnastrazole-placebo-clomipheneAnastrazole-clomiphene-placebo
Arm/Group Description placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capplacebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
Overall Number of Participants Analyzed 434344
Measure Type: Number
Unit of Measure: score on a scale
Patients 19-24 14
45
47
60
59
52
Patients 13-18 17
27
72
43
65
60
Patients 7-12 45
65
35
42
60
54
Patients 1-6 41

52

70
12
2. PrimaryOutcome
Title IIEF (International Index of Erectile Function) Score - Week 16
Description 15 item self reported erectile function over the past 8 weeks. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75
Time Frame Week 16
Outcome Measure Data
Analysis Population Description
Total IIEF reported at the end of the second 8 week period - at week 16 Data for patient 23 was not collected in the placebo-clomiphene-anastrazole arm.
 
Arm/Group title Placebo-anastrazole-clomiphenePlacebo-clomiphene-anastrazoleClomiphene-placebo-anastrazoleClomiphene-anastrazole-placeboAnastrazole-placebo-clomipheneAnastrazole-clomiphene-placebo
Arm/Group Description placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capplacebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
Overall Number of Participants Analyzed 434444
Measure Type: Number
Unit of Measure: score on a scale
Patients 19-24 18
59
47
51
38
62
Patients 13-18 15
33
58
37
62
53
Patients 7-12 38
66
55
50
56
43
Patients 1-6 37

45
35
53
45
3. PrimaryOutcome
Title IIEF (International Index of Erectile Function) Score - Week 8
Description 15 item self reported erectile function over the past 8 weeks. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75
Time Frame Week 8
Outcome Measure Data
Analysis Population Description
Total IIEF reported at the end of the first 8 week period
 
Arm/Group title Placebo-anastrazole-clomiphenePlacebo-clomiphene-anastrazoleClomiphene-placebo-anastrazoleClomiphene-anastrazole-placeboAnastrazole-placebo-clomipheneAnastrazole-clomiphene-placebo
Arm/Group Description placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capplacebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
Overall Number of Participants Analyzed 444444
Measure Type: Number
Unit of Measure: score on a scale
Patients 19-24 53
25
45
70
65
63
Patients 13-18 28
43
65
32
59
55
Patients 7-12 37
72
45
63
51
45
Patients 1-6 35
66
20
32
55
25
4. PrimaryOutcome
Title IIEF (International Index of Erectile Function) Score - Screen
Description 15 item self reported erectile function. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75
Time Frame At baseline
Outcome Measure Data
Analysis Population Description
Total IIEF reported at the initial encounter.
 
Arm/Group title Placebo-anastrazole-clomiphenePlacebo-clomiphene-anastrazoleClomiphene-placebo-anastrazoleClomiphene-anastrazole-placeboAnastrazole-placebo-clomipheneAnastrazole-clomiphene-placebo
Arm/Group Description placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capplacebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
Overall Number of Participants Analyzed 444444
Measure Type: Number
Unit of Measure: score on a scale
Patients 19-24 62
18
47
55
52
50
Patients 13-18 32
58
45
41
46
55
Patients 7-12 55
36
32
45
57
57
Patients 1-6 24
57
41
57
43
34
5. SecondaryOutcome
Title EHS (Erectile Hardness Score) - Screen
Description Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid
Time Frame Baseline
Outcome Measure Data
Analysis Population Description
Score 0-4 at the initial encounter week 0
 
Arm/Group title Placebo-anastrazole-clomiphenePlacebo-clomiphene-anastrazoleClomiphene-placebo-anastrazoleClomiphene-anastrazole-placeboAnastrazole-placebo-clomipheneAnastrazole-clomiphene-placebo
Arm/Group Description placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capplacebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
Overall Number of Participants Analyzed 444444
Measure Type: Number
Unit of Measure: score on a scale
Patients 19-24 3
3
3
3
3
3
Patients 13-18 3
1
2
3
3
3
Patients 7-12 3
3
2
3
3
3
Patients 1-6 3
3
2
3
3
3
6. SecondaryOutcome
Title LH - Week 8
Description Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods.
Time Frame Week 8
Outcome Measure Data
Analysis Population Description
LH measured at week 8 Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm
 
Arm/Group title Placebo-anastrazole-clomiphenePlacebo-clomiphene-anastrazoleClomiphene-placebo-anastrazoleClomiphene-anastrazole-placeboAnastrazole-placebo-clomipheneAnastrazole-clomiphene-placebo
Arm/Group Description placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capplacebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
Overall Number of Participants Analyzed 434444
Measure Type: Number
Unit of Measure: IU/L
Patients 19-24 7.3
6.7
6.9
7.5
11.5
4.2
Patients 13-18 3
3.3
4.7
6.1
6.9
2.9
Patients 7-12 1.9
3.6
12.6
10.7
4
5.2
Patients 1-6 6.3

17.3
9.9
5.1
9.1
7. SecondaryOutcome
Title LH - Screen
Description Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods.
Time Frame Baseline
Outcome Measure Data
Analysis Population Description
LH measured at initial encounter Data for pt 23 in placebo-clomiphene-anastrazole not collected
 
Arm/Group title Placebo-anastrazole-clomiphenePlacebo-clomiphene-anastrazoleClomiphene-placebo-anastrazoleClomiphene-anastrazole-placeboAnastrazole-placebo-clomipheneAnastrazole-clomiphene-placebo
Arm/Group Description placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capplacebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
Overall Number of Participants Analyzed 434444
Measure Type: Number
Unit of Measure: IU/L
Patients 19-24 6.8
6
5.9
4.7
4.1
6.3
Patients 13-18 3.1
2.4
3.3
4.1
3.5
1.1
Patients 7-12 1.7
3.5
4.1
2.4
3.8
3.4
Patients 1-6 3.4

6.8
3.8
3.6
3.5
8. SecondaryOutcome
Title EHS (Erectile Hardness Score) - Week 24
Description Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid
Time Frame Week 24
Outcome Measure Data
Analysis Population Description
Score 0-4 at the end of Week 24 no data was collected for patient 15 in clomiphene-anastrazole-placebo no data was collected for patient 23 in placebo-clomiphene-anastrazole
 
Arm/Group title Placebo-anastrazole-clomiphenePlacebo-clomiphene-anastrazoleClomiphene-placebo-anastrazoleClomiphene-anastrazole-placeboAnastrazole-placebo-clomipheneAnastrazole-clomiphene-placebo
Arm/Group Description placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capplacebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
Overall Number of Participants Analyzed 434344
Measure Type: Number
Unit of Measure: score on a scale
Patients 19-24 1
1
3
3
1
3
Patients 13-18 1
2
4
3
4
3
Patients 7-12 3
3
2
2
3
3
Patients 1-6 3

2

4
3
9. SecondaryOutcome
Title Estradiol - Week 16
Description Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24 An entered value of 4.9 means the measure was <5
Time Frame Week 16
Outcome Measure Data
Analysis Population Description
Estradiol measurement at the end of Week 16 Data was not collected for patient 2 in anastrazole-placebo-clomiphene arm Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm
 
Arm/Group title Placebo-anastrazole-clomiphenePlacebo-clomiphene-anastrazoleClomiphene-placebo-anastrazoleClomiphene-anastrazole-placeboAnastrazole-placebo-clomipheneAnastrazole-clomiphene-placebo
Arm/Group Description placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capplacebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
Overall Number of Participants Analyzed 434434
Measure Type: Number
Unit of Measure: pg/mL
Patients 19-24 4.9
37
15.9
14.8
28.3
48.5
Patients 13-18 4.9
28.2
13.1
23.8
15
20.1
Patients 7-12 6.8
56.9
14.4
12.8
21.6
13.1
Patients 1-6 5

17.9
8.9

39.5
10. SecondaryOutcome
Title Estradiol - Week 8
Description Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24 An entered value of 4.9 means the measure was <5
Time Frame Week 8
Outcome Measure Data
Analysis Population Description
Estradiol measurement at the end of Week 8 Data was not collected for patient 2 in anastrazole-placebo-clomiphene arm Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm
 
Arm/Group title Placebo-anastrazole-clomiphenePlacebo-clomiphene-anastrazoleClomiphene-placebo-anastrazoleClomiphene-anastrazole-placeboAnastrazole-placebo-clomipheneAnastrazole-clomiphene-placebo
Arm/Group Description placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capplacebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
Overall Number of Participants Analyzed 434434
Measure Type: Number
Unit of Measure: pg/mL
Patients 19-24 27.4
10
39.1
51.7
10.7
7.4
Patients 13-18 15.9
18.5
33.5
25.1
4.9
9.7
Patients 7-12 9.3
20.8
45
70.1
15.1
7
Patients 1-6 22.5

94.5
49.8

11.2
11. SecondaryOutcome
Title EHS (Erectile Hardness Score) - Week 16
Description Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid
Time Frame Week 16
Outcome Measure Data
Analysis Population Description
Score 0-4 at the end of Week 16 Data for patient 23 was not collected in placebo-clomiphene-anastrazole arm
 
Arm/Group title Placebo-anastrazole-clomiphenePlacebo-clomiphene-anastrazoleClomiphene-placebo-anastrazoleClomiphene-anastrazole-placeboAnastrazole-placebo-clomipheneAnastrazole-clomiphene-placebo
Arm/Group Description placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capplacebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
Overall Number of Participants Analyzed 434444
Measure Type: Number
Unit of Measure: score on a scale
Patients 19-24 1
1
3
3
1
3
Patients 13-18
2
4
3
4
3
Patients 7-12 3
4
3
3
3
3
Patients 1-6 3

2
2
3
3
12. SecondaryOutcome
Title EHS (Erectile Hardness Score) - Week 8
Description Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid
Time Frame Week 8
Outcome Measure Data
Analysis Population Description
Score 0-4 at the end of Week 8
 
Arm/Group title Placebo-anastrazole-clomiphenePlacebo-clomiphene-anastrazoleClomiphene-placebo-anastrazoleClomiphene-anastrazole-placeboAnastrazole-placebo-clomipheneAnastrazole-clomiphene-placebo
Arm/Group Description placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capplacebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
Overall Number of Participants Analyzed 444444
Measure Type: Number
Unit of Measure: score on a scale
Patients 19-24 3
1
2
3
3
3
Patients 13-18 3
1
3
3
3
3
Patients 7-12 2
4
2
3
3
3
Patients 1-6 1
3
1
1
4
1
13. SecondaryOutcome
Title SEP #1-3 Cumulative - Week 16
Description Questions 1, 2, and 3 for the Sexual Encounter Profile have been cumulatively added. 1 - yes and 0 - no have been added for questions 1-3 to determine a total value from 0-3. 0-3: cumulative score from SEP questions 1, 2, and 3 Higher values (3) are considered to be a better outcomes relative to lower numbers (0) 3 is better than 2 is better than 1 is better than 0
Time Frame Week 16
Outcome Measure Data
Analysis Population Description
SEP measured at the end of week 16 data not collected for pt 3,15 in CAP arm data not collected for pt 5,11,23 in PCA arm
 
Arm/Group title Placebo-anastrazole-clomiphenePlacebo-clomiphene-anastrazoleClomiphene-placebo-anastrazoleClomiphene-anastrazole-placeboAnastrazole-placebo-clomipheneAnastrazole-clomiphene-placebo
Arm/Group Description placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capplacebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
Overall Number of Participants Analyzed 414244
Measure Type: Number
Unit of Measure: score on a scale
Patients 19-24 1
3
3
3
3
3
Patients 13-18 2

3
3
3
4
Patients 7-12

3

3
3
Patients 1-6 2

1

3
2
14. SecondaryOutcome
Title SEP #1-3 Cumulative - Week 24
Description Questions 1, 2, and 3 for the Sexual Encounter Profile have been cumulatively added. 1 - yes and 0 - no have been added for questions 1-3 to determine a total value from 0-3. 0-3: cumulative score from SEP questions 1, 2, and 3 Higher values (3) are considered to be a better outcomes relative to lower numbers (0) 3 is better than 2 is better than 1 is better than 0
Time Frame Week 24
Outcome Measure Data
Analysis Population Description
SEP measured at the end of week 24 data not collected for pt 1,13 in ACP arm data not collected for pt 3, 15 in CAP arm data not collected for pt 22 in CPA arm data not collected for pt 11,23 PCA arm
 
Arm/Group title Placebo-anastrazole-clomiphenePlacebo-clomiphene-anastrazoleClomiphene-placebo-anastrazoleClomiphene-anastrazole-placeboAnastrazole-placebo-clomipheneAnastrazole-clomiphene-placebo
Arm/Group Description placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capplacebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
Overall Number of Participants Analyzed 423242
Measure Type: Number
Unit of Measure: score on a scale
Patients 19-24 1

2
3
3
3
Patients 13-18 2
3
1
3
3
3
Patients 7-12

3

3

Patients 1-6 2



3

15. SecondaryOutcome
Title LH - Week 16
Description Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods.
Time Frame Week 16
Outcome Measure Data
Analysis Population Description
LH measured at week 16 Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm
 
Arm/Group title Placebo-anastrazole-clomiphenePlacebo-clomiphene-anastrazoleClomiphene-placebo-anastrazoleClomiphene-anastrazole-placeboAnastrazole-placebo-clomipheneAnastrazole-clomiphene-placebo
Arm/Group Description placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capplacebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
Overall Number of Participants Analyzed 434444
Measure Type: Number
Unit of Measure: IU/L
Patients 19-24 7.4
13
4.9
4.2
4.3
7.8
Patients 13-18 6.4
5.2
1.9
6.6
2.1
1.9
Patients 7-12 3.8
13.9
4.9
2.2
4.8
6.9
Patients 1-6 8.9

5.4
6.3
4.6
6.8
16. SecondaryOutcome
Title SEP #1-3 Cumulative - Week 8
Description Questions 1, 2, and 3 for the Sexual Encounter Profile have been cumulatively added. 1 - yes and 0 - no have been added for questions 1-3 to determine a total value from 0-3. 0-3: cumulative score from SEP questions 1, 2, and 3 Higher values (3) are considered to be a better outcomes relative to lower numbers (0) 3 is better than 2 is better than 1 is better than 0
Time Frame Week 8
Outcome Measure Data
Analysis Population Description
SEP measured at the end of week 8 data not collected for pt 11,17 in PCA arm data not collected for pt 13 in ACP arm data not collected for pt 15 in CAP arm data not collected for pt 22 in CPA arm
 
Arm/Group title Placebo-anastrazole-clomiphenePlacebo-clomiphene-anastrazoleClomiphene-placebo-anastrazoleClomiphene-anastrazole-placeboAnastrazole-placebo-clomipheneAnastrazole-clomiphene-placebo
Arm/Group Description placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capplacebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
Overall Number of Participants Analyzed 423343
Measure Type: Number
Unit of Measure: score on a scale
Patients 19-24 2
1
1
3
3
3
Patients 13-18 2
3
2
2
2
2
Patients 7-12 3

1
1
3
3
Patients 1-6 4



3

17. SecondaryOutcome
Title SEP #1-3 Cumulative - Screen
Description Questions 1, 2, and 3 for the Sexual Encounter Profile have been cumulatively added. 1 - yes and 0 - no have been added for questions 1-3 to determine a total value from 0-3. 0-3: cumulative score from SEP questions 1, 2, and 3 Higher values (3) are considered to be a better outcomes relative to lower numbers (0) 3 is better than 2 is better than 1 is better than 0
Time Frame Baseline
Outcome Measure Data
Analysis Population Description
SEP measured at the initial encounter Baseline SPEP was not measured for participants 1-24 Table included for completeness
 
Arm/Group title Placebo-anastrazole-clomiphenePlacebo-clomiphene-anastrazoleClomiphene-placebo-anastrazoleClomiphene-anastrazole-placeboAnastrazole-placebo-clomipheneAnastrazole-clomiphene-placebo
Arm/Group Description placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capplacebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
Overall Number of Participants Analyzed
Measure Type:
Unit of Measure:
18. SecondaryOutcome
Title SHBG - Week 24
Description Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24
Time Frame Week 24
Outcome Measure Data
Analysis Population Description
SHBG measured at week 24 Data was not collected for patient 15 in clomiphene-anastrazole-placebo arm Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm Data was not collected for patient 24 in placebo-anastrazole-clomiphene arm
 
Arm/Group title Placebo-anastrazole-clomiphenePlacebo-clomiphene-anastrazoleClomiphene-placebo-anastrazoleClomiphene-anastrazole-placeboAnastrazole-placebo-clomipheneAnastrazole-clomiphene-placebo
Arm/Group Description placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capplacebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
Overall Number of Participants Analyzed 334344
Measure Type: Number
Unit of Measure: nmol/L
Patients 7-12 34.1
13.8
25.3
24.4
16
29
Patients 1-6 23.6
29.7
25.2
15.1
41.8
33.8
Patients 13-18 17.5
17.3
20.1
33.8
26
23.2


13.7

21.7
14.6
19. SecondaryOutcome
Title SHBG - Week 16
Description Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24
Time Frame Week 16
Outcome Measure Data
Analysis Population Description
SHBG measured at week 16 Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm
 
Arm/Group title Placebo-anastrazole-clomiphenePlacebo-clomiphene-anastrazoleClomiphene-placebo-anastrazoleClomiphene-anastrazole-placeboAnastrazole-placebo-clomipheneAnastrazole-clomiphene-placebo
Arm/Group Description placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capplacebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
Overall Number of Participants Analyzed 434444
Measure Type: Number
Unit of Measure: nmol/L
Patients 1-6 17.7
33.3
16.4
26.6
15.3
30.7
Patients 7-12 23
16.7
31
13.8
35.5
22.3
Patients 19-24 31
17.2
13.9
14.2
17.2
26.8
Patients 13-18 16.6

22.8
35
24.8
39.3
20. SecondaryOutcome
Title SHBG - Week 8
Description Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24
Time Frame Week 8
Outcome Measure Data
Analysis Population Description
SHBG measured at week 8 Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm
 
Arm/Group title Placebo-anastrazole-clomiphenePlacebo-clomiphene-anastrazoleClomiphene-placebo-anastrazoleClomiphene-anastrazole-placeboAnastrazole-placebo-clomipheneAnastrazole-clomiphene-placebo
Arm/Group Description placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capplacebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
Overall Number of Participants Analyzed 434444
Measure Type: Number
Unit of Measure: nmol/L
Patients 19-24 30.7
14.3
20.9
42.7
20.1
28.1
Patients 13-18 17.6
24.1
30.9
21.6
16.1
26.9
Patients 7-12 25.7
23.9
27.2
26
12.7
23.4
Patients 1-6 21.6

29.8
18.4
38.2
10
21. SecondaryOutcome
Title SHBG - Screen
Description Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24
Time Frame Baseline
Outcome Measure Data
Analysis Population Description
SHBG measured at initial encounter Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm
 
Arm/Group title Placebo-anastrazole-clomiphenePlacebo-clomiphene-anastrazoleClomiphene-placebo-anastrazoleClomiphene-anastrazole-placeboAnastrazole-placebo-clomipheneAnastrazole-clomiphene-placebo
Arm/Group Description placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capplacebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
Overall Number of Participants Analyzed 434444
Measure Type: Number
Unit of Measure: nmol/L
Patients 19-24 30.6
16.9
11.6
35.5
22
28.6
Patients 13-18 14.8
20.9
20
21.4
17.5
23.5
Patients 7-12 26.8
26.2
26.4
23.5
12.6
30.7
Patients 1-6 24.1

31.7
20
35.2
13.9
22. SecondaryOutcome
Title Estradiol - Week 24
Description Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24 An entered value of 4.9 means the measure was <5
Time Frame Week 24
Outcome Measure Data
Analysis Population Description
Estradiol measurement at the end of Week 24 Data was not collected for patient 15 in clomiphene-anastrazole-placebo arm Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm Data was not collected for patient 24 in placebo-anastrazole-clomiphene arm
 
Arm/Group title Placebo-anastrazole-clomiphenePlacebo-clomiphene-anastrazoleClomiphene-placebo-anastrazoleClomiphene-anastrazole-placeboAnastrazole-placebo-clomipheneAnastrazole-clomiphene-placebo
Arm/Group Description placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capplacebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
Overall Number of Participants Analyzed 334344
Measure Type: Number
Unit of Measure: pg/mL
Patients 13-18 29.3
4.9
4.9
19
39.4
22.2
Patients 7-12 85.9
11.6
9.2
6.6
36.4
25.5
Patients 1-6 41.1
18.1
5
16.2
49.1
12.5


9.5

43.9
22.5
23. SecondaryOutcome
Title Estradiol - Screen
Description Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24
Time Frame Baseline
Outcome Measure Data
Analysis Population Description
Estradiol measurement at initial encounter Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm
 
Arm/Group title Placebo-anastrazole-clomiphenePlacebo-clomiphene-anastrazoleClomiphene-placebo-anastrazoleClomiphene-anastrazole-placeboAnastrazole-placebo-clomipheneAnastrazole-clomiphene-placebo
Arm/Group Description placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capplacebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
Overall Number of Participants Analyzed 444444
Measure Type: Number
Unit of Measure: pg/mL
Patients 19-24 26.8
15.9
11
26.6
15.5
9.5
Patients 13-18 13.1
18.6
14.1
16.2
20.1
13.3
Patients 7-12 10.9
15.9
11.4
21.3
19.3
9
Patients 1-6 18.4

13.5
9.6
8.1
21.6
24. SecondaryOutcome
Title Free Testosterone - Week 24
Description Measure of Free Testosterone
Time Frame Week 24
Outcome Measure Data
Analysis Population Description
FT measured at the end of Week 24 Data not collected for patient 8 in APC arm Data was not collected for patient 15 in clomiphene-anastrazole-placebo arm Data was not collected for patient 18 in placebo-anastrazole-clomiphene arm Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm No data collected pt 24 in PAC arm
 
Arm/Group title Placebo-anastrazole-clomiphenePlacebo-clomiphene-anastrazoleClomiphene-placebo-anastrazoleClomiphene-anastrazole-placeboAnastrazole-placebo-clomipheneAnastrazole-clomiphene-placebo
Arm/Group Description placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capplacebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
Overall Number of Participants Analyzed 234334
Measure Type: Number
Unit of Measure: ng/dl
Patients 7-12 25.27
8.65
11.28
6.25
19.35
10.51
Patients 1-6 19.31
15.49
16.82
6.11
13.54
5.82

11.63
18.19
11.09
13.74
11.82


17.89


6.11
25. SecondaryOutcome
Title Free Testosterone - Week 16
Description Measure of Free Testosterone
Time Frame Week 16
Outcome Measure Data
Analysis Population Description
FT measured at the end of Week 16 Data was not collected for patient 15 in clomiphene-anastrazole-placebo arm Data was not collected for patient 22 in clomiphene-placebo-anastrazole arm Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm
 
Arm/Group title Placebo-anastrazole-clomiphenePlacebo-clomiphene-anastrazoleClomiphene-placebo-anastrazoleClomiphene-anastrazole-placeboAnastrazole-placebo-clomipheneAnastrazole-clomiphene-placebo
Arm/Group Description placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capplacebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
Overall Number of Participants Analyzed 433344
Measure Type: Number
Unit of Measure: ng/dl
Patients 13-18 7.58
16.38
6.63
11.22
9.46
14.98
Patients 7-12 13.47
14.57
9.63
14.7
5.98
10.17
Patients 1-6 17.47
19.21
12.67
12.27
5.7
8.83
Patients 19-24 11.62



16.37
14.16
26. SecondaryOutcome
Title Free Testosterone - Week 8
Description Measure of Free Testosterone
Time Frame Week 8
Outcome Measure Data
Analysis Population Description
FT measured at the end of Week 8 Data was not collected for patient 8 in anastrazole-placebo-clomiphene arm Data was not collected for patient 15 in clomiphene-anastrazole-placebo arm Data was not collected for patient 18 in placebo-anastrazole-clomiphene arm Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm
 
Arm/Group title Placebo-anastrazole-clomiphenePlacebo-clomiphene-anastrazoleClomiphene-placebo-anastrazoleClomiphene-anastrazole-placeboAnastrazole-placebo-clomipheneAnastrazole-clomiphene-placebo
Arm/Group Description placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capplacebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
Overall Number of Participants Analyzed 334334
Measure Type: Number
Unit of Measure: ng/dl
Patients 19-24 6.04
8.91
15.71
11.37
20.01
17.44
Patients 7-12 5.3
9.4
21.71
19.33
15.18
21.61
Patients 1-6 12.3
2.71
27.79
17.72
21.8
15.63


35.27


19.46
27. SecondaryOutcome
Title Free Testosterone - Screen
Description Measure of Free Testosterone
Time Frame Baseline
Outcome Measure Data
Analysis Population Description
FT measured at initial encounter Data was not collected for patient 15 in clomiphene-anastrazole-placebo arm Data was not collected for patient 18 in placebo-anastrazole-clomiphene arm Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm
 
Arm/Group title Placebo-anastrazole-clomiphenePlacebo-clomiphene-anastrazoleClomiphene-placebo-anastrazoleClomiphene-anastrazole-placeboAnastrazole-placebo-clomipheneAnastrazole-clomiphene-placebo
Arm/Group Description placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capplacebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
Overall Number of Participants Analyzed 334344
Measure Type: Number
Unit of Measure: ng/dl
Patients 19-24 6.33
9.49
7.71
6.52
7.27
2.19
Patients 7-12 5.78
5.82
4.86
6.07
12.27
9.56
Patients 1-6 7.86
6.27
9.9
7.28
9.31
6.74


8.82

6.99
8.4
28. SecondaryOutcome
Title FSH - Week 24
Description Lab Values for follicle stimulating hormone
Time Frame Week 24
Outcome Measure Data
Analysis Population Description
FSH measured at Week 24 Data was not collected for patient 15 in clomiphene-anastrazole-placebo arm Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm Data was not collected for patient 24 in placebo-anastrazole-clomiphene arm
 
Arm/Group title Placebo-anastrazole-clomiphenePlacebo-clomiphene-anastrazoleClomiphene-placebo-anastrazoleClomiphene-anastrazole-placeboAnastrazole-placebo-clomipheneAnastrazole-clomiphene-placebo
Arm/Group Description placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capplacebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
Overall Number of Participants Analyzed 334344
Measure Type: Number
Unit of Measure: IU/L
Patients 13-18 10.4
5.9
5.8
5
29.7
4.8
Patients 7-12 14.5
5.2
7.2
6
7.2
2
Patients 1-6 4
6.5
3.7
3
15.1
4.4


5.2

4.8
4.1
29. SecondaryOutcome
Title FSH - Week 16
Description Lab Values for follicle stimulating hormone
Time Frame Week 16
Outcome Measure Data
Analysis Population Description
FSH measured at Week 16 Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm
 
Arm/Group title Placebo-anastrazole-clomiphenePlacebo-clomiphene-anastrazoleClomiphene-placebo-anastrazoleClomiphene-anastrazole-placeboAnastrazole-placebo-clomipheneAnastrazole-clomiphene-placebo
Arm/Group Description placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capplacebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
Overall Number of Participants Analyzed 434444
Measure Type: Number
Unit of Measure: IU/L
Patients 19-24 8.9
8.3
4.2
6.2
11.4
12.8
Patients 13-18 11.5
2.6
3.3
1.2
3.8
1.9
Patients 7-12 6.5
10.7
2.9
6
3.7
7.2
Patients 1-6 6.8

5.3
4.2
4.3
7
30. SecondaryOutcome
Title FSH - Week 8
Description Lab Values for follicle stimulating hormone
Time Frame Week 8
Outcome Measure Data
Analysis Population Description
FSH measured at Week 8 Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm
 
Arm/Group title Placebo-anastrazole-clomiphenePlacebo-clomiphene-anastrazoleClomiphene-placebo-anastrazoleClomiphene-anastrazole-placeboAnastrazole-placebo-clomipheneAnastrazole-clomiphene-placebo
Arm/Group Description placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capplacebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
Overall Number of Participants Analyzed 444444
Measure Type: Number
Unit of Measure: IU/L
Patients 19-24 4.4
4.7
8.1
6.1
20.3
11.3
Patients 13-18 6
2.2
6.3
1.8
8.3
3
Patients 7-12 4.2
3.4
3.03
7.8
6.2
7.7
Patients 1-6 4.1

16.2
8.2
4.3
5.4
31. SecondaryOutcome
Title FSH - Screen
Description Lab Values for follicle stimulating hormone
Time Frame Baseline
Outcome Measure Data
Analysis Population Description
FSH measured at initial encounter Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm
 
Arm/Group title Placebo-anastrazole-clomiphenePlacebo-clomiphene-anastrazoleClomiphene-placebo-anastrazoleClomiphene-anastrazole-placeboAnastrazole-placebo-clomipheneAnastrazole-clomiphene-placebo
Arm/Group Description placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capplacebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
Overall Number of Participants Analyzed 434444
Measure Type: Number
Unit of Measure: IU/L
Patients 19-24 5.1
4.4
4.4
4.5
10
5.5
Patients 13-18 5.7
1.8
4
1.7
5.1
1.6
Patients 7-12 3.5
3.3
2.9
3.9
3.7
5.7
Patients 1-6 3.6

4.5
5.5
2.4
2.7
32. SecondaryOutcome
Title LH - Week 24
Description Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods.
Time Frame Week 24
Outcome Measure Data
Analysis Population Description
LH measured at week 24 No data for patient 13 collected in clomiphene-anastrazole-placebo arm Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm Data was not collected for patient 24 in placebo-anastrazole-clomiphene arm
 
Arm/Group title Placebo-anastrazole-clomiphenePlacebo-clomiphene-anastrazoleClomiphene-placebo-anastrazoleClomiphene-anastrazole-placeboAnastrazole-placebo-clomipheneAnastrazole-clomiphene-placebo
Arm/Group Description placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capplacebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
Overall Number of Participants Analyzed 334344
Measure Type: Number
Unit of Measure: IU/L
Patients 13-18 8.1
7.1
5.4
4.7
15.1
2.7
Patients 7-12 10.5
2.9
7.6
5.9
5.4
2.2
Patients 1-6 7.7
5
6.4
3.4
12.6
6.1


6.4

4.1
3
33. SecondaryOutcome
Title ADAM (Androgen Deficiency in the Aging Male) Score - Week 24
Description Self reported quantification of hypogonadism. 10 "yes" or "no" questions. A positive (yes) questionnaire result is defined as a "yes or 1" and a negative (no) questionnaire result is defined as a "no or 0" to question 1 or question 7 or any 3 other questions. Yes (1) represents a better outcome than No (1) In Data Entry: Yes - 1 No - 0
Time Frame Week 24
Outcome Measure Data
Analysis Population Description
ADAM score at the end of Week 24 No data collected pt 15 in clomiphene-anastrazole-placebo arm no data collected for pt 16 clomiphene-placebo-anastrazole arm no data collected for pt 23 placebo-clomiphene-anastrazole arm
 
Arm/Group title Placebo-anastrazole-clomiphenePlacebo-clomiphene-anastrazoleClomiphene-placebo-anastrazoleClomiphene-anastrazole-placeboAnastrazole-placebo-clomipheneAnastrazole-clomiphene-placebo
Arm/Group Description placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capplacebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
Overall Number of Participants Analyzed 433344
Measure Type: Number
Unit of Measure: score on a scale
Patients 19-24 1
1

1
1
1
Patients 13-18 1
1
1
1


Patients 7-12 1

1

1
1
Patients 1-6 1




1
34. SecondaryOutcome
Title ADAM (Androgen Deficiency in the Aging Male) Score - Week 16
Description Self reported quantification of hypogonadism. 10 "yes" or "no" questions. A positive (yes) questionnaire result is defined as a "yes or 1" and a negative (no) questionnaire result is defined as a "no or 0" to question 1 or question 7 or any 3 other questions. Yes (1) represents a better outcome than No (1) In Data Entry: Yes - 1 No - 0
Time Frame Week 16
Outcome Measure Data
Analysis Population Description
ADAM score at the end of Week 16 Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm
 
Arm/Group title Placebo-anastrazole-clomiphenePlacebo-clomiphene-anastrazoleClomiphene-placebo-anastrazoleClomiphene-anastrazole-placeboAnastrazole-placebo-clomipheneAnastrazole-clomiphene-placebo
Arm/Group Description placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capplacebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
Overall Number of Participants Analyzed 434444
Measure Type: Number
Unit of Measure: score on a scale
Patients 19-24 1

1
1
1
1
Patients 13-18 1
1

1
1
1
Patients 7-12 1

1
1
1
1
Patients 1-6 1

1
1
1
1
35. SecondaryOutcome
Title ADAM (Androgen Deficiency in the Aging Male) Score - Week 8
Description Self reported quantification of hypogonadism. 10 "yes" or "no" questions. A positive (yes) questionnaire result is defined as a "yes or 1" and a negative (no) questionnaire result is defined as a "no or 0" to question 1 or question 7 or any 3 other questions. Yes (1) represents a better outcome than No (1) In Data Entry: Yes - 1 No - 0
Time Frame Week 8
Outcome Measure Data
Analysis Population Description
ADAM score at the end of Week 8 Data was not collected for patient 19 in anastrazole-clomiphene-placebo arm
 
Arm/Group title Placebo-anastrazole-clomiphenePlacebo-clomiphene-anastrazoleClomiphene-placebo-anastrazoleClomiphene-anastrazole-placeboAnastrazole-placebo-clomipheneAnastrazole-clomiphene-placebo
Arm/Group Description placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capplacebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
Overall Number of Participants Analyzed 444443
Measure Type: Number
Unit of Measure: score on a scale
Patients 19-24 1
1
1
1

1
Patients 13-18 1


1
1
1
Patients 7-12 1

1

1
1
Patients 1-6 1
1
1
1
1

36. SecondaryOutcome
Title ADAM (Androgen Deficiency in the Aging Male) Score - Screen
Description Self reported quantification of hypogonadism. 10 "yes" or "no" questions. A positive (yes) questionnaire result is defined as a "yes or 1" and a negative (no) questionnaire result is defined as a "no or 0" to question 1 or question 7 or any 3 other questions. Yes (1) represents a better outcome than No (1) In Data Entry: Yes - 1 No - 0
Time Frame Baseline
Outcome Measure Data
Analysis Population Description
Initial Evaluation for ADAM score - Week 0
 
Arm/Group title Placebo-anastrazole-clomiphenePlacebo-clomiphene-anastrazoleClomiphene-placebo-anastrazoleClomiphene-anastrazole-placeboAnastrazole-placebo-clomipheneAnastrazole-clomiphene-placebo
Arm/Group Description placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capplacebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
Overall Number of Participants Analyzed 444444
Measure Type: Number
Unit of Measure: score on a scale
Patients 19-24 1
1
1
1
1
1
Patients 13-18 1
1
1
1
1
1
Patients 7-12 1
1
1
1
1
1
Patients 1-6 1
1
1
1
1
1
37. SecondaryOutcome
Title Normalized Testosterone - Week 24
Description Normalized at >350ng/dl
Time Frame Week 24
Outcome Measure Data
Analysis Population Description
Normalized Testosterone measured at the end of the 24th week Data was not collected for patient 15 clomiphene-anastrazole-placebo Data for patient 23 was not collected for placebo-clomiphene-anastrazole arm Data was not collected for patient 24 in placebo-anastrazole-clomiphene
 
Arm/Group title Placebo-anastrazole-clomiphenePlacebo-clomiphene-anastrazoleClomiphene-placebo-anastrazoleClomiphene-anastrazole-placeboAnastrazole-placebo-clomipheneAnastrazole-clomiphene-placebo
Arm/Group Description placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capplacebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
Overall Number of Participants Analyzed 334344
Measure Type: Number
Unit of Measure: ng/dl
Patients 13-18 195
487
486
274
630
196
Patients 7-12 972
375
447
440
449
446
Patients 1-6 596
412
531
214
519
269


537

793
268
38. SecondaryOutcome
Title Normalized Testosterone - Week 16
Description Normalized at >350ng/dl
Time Frame Week 16
Outcome Measure Data
Analysis Population Description
Normalized Testosterone measured at the end of the 16th week Data for patient 23 was not collected for placebo-clomiphene-anastrazole arm
 
Arm/Group title Placebo-anastrazole-clomiphenePlacebo-clomiphene-anastrazoleClomiphene-placebo-anastrazoleClomiphene-anastrazole-placeboAnastrazole-placebo-clomipheneAnastrazole-clomiphene-placebo
Arm/Group Description placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capplacebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
Overall Number of Participants Analyzed 434444
Measure Type: Number
Unit of Measure: ng/dl
Patients 7-12 520
585
206
124
191
329
Patients 1-6 502
396
403
451
200
337
Patients 13-18 283
696
391
338
591
437
Patients 19-24 484

288
456
323
609
39. SecondaryOutcome
Title Normalized Testosterone - Week 8
Description Normalized at >350ng/dl
Time Frame Week 8
Outcome Measure Data
Analysis Population Description
Normalized Testosterone measured at the end of the first 8 week period Data for patient 23 was not collected for placebo-clomiphene-anastrazole arm
 
Arm/Group title Placebo-anastrazole-clomiphenePlacebo-clomiphene-anastrazoleClomiphene-placebo-anastrazoleClomiphene-anastrazole-placeboAnastrazole-placebo-clomipheneAnastrazole-clomiphene-placebo
Arm/Group Description placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capplacebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
Overall Number of Participants Analyzed 434444
Measure Type: Number
Unit of Measure: ng/dl
Patients 7-12 298
271
917
693
296
387
Patients 1-6 470
133
1316
566
757
484
Patients 19-24 296
270
497
592
676
545
Patients 13-18 139

527
216
453
607
40. SecondaryOutcome
Title Normalized Testosterone - Screen
Description Normalized at >350ng/dl
Time Frame Baseline
Outcome Measure Data
Analysis Population Description
Normalized Testosterone measured week 0 - initial screen Data not collected for patient 23 in placebo-clomiphene-anastrazole arm
 
Arm/Group title Placebo-anastrazole-clomiphenePlacebo-clomiphene-anastrazoleClomiphene-placebo-anastrazoleClomiphene-anastrazole-placeboAnastrazole-placebo-clomipheneAnastrazole-clomiphene-placebo
Arm/Group Description placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capplacebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
Overall Number of Participants Analyzed 434444
Measure Type: Number
Unit of Measure: ng/dl
Patients 19-24 289
321
244
306
291
95
Patients 13-18 148
214
206
268
328
347
Patients 7-12 243
315
300
194
237
293
Patients 1-6 321

367
226
330
205
Adverse Events
Time Frame Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting.
Adverse Event Reporting Description The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.
 
Arm/Group Title Placebo-anastrazole-clomiphenePlacebo-clomiphene-anastrazoleClomiphene-placebo-anastrazoleClomiphene-anastrazole-placeboAnastrazole-placebo-clomipheneAnastrazole-clomiphene-placebo
Arm/Group Description placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capplacebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capclomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Capanastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap
All-Cause Mortality
  Anastrazole-clomiphene-placebo Anastrazole-placebo-clomiphene Clomiphene-anastrazole-placebo Clomiphene-placebo-anastrazole Placebo-clomiphene-anastrazole Placebo-anastrazole-clomiphene
Affected at Risk (%) Affected at Risk (%) Affected at Risk (%) Affected at Risk (%) Affected at Risk (%) Affected at Risk (%)
Total 0/4 (0.00%) 0/4 (0.00%) 0/4 (0.00%) 0/4 (0.00%) 0/4 (0.00%) 0/4 (0.00%)
Total
Total, all-cause mortality 0 /4 (0.00%) 0 /4 (0.00%) 0 /4 (0.00%) 0 /4 (0.00%) 0 /4 (0.00%) 0 /4 (0.00%)
Serious Adverse Events
  Anastrazole-clomiphene-placebo Anastrazole-placebo-clomiphene Clomiphene-anastrazole-placebo Clomiphene-placebo-anastrazole Placebo-clomiphene-anastrazole Placebo-anastrazole-clomiphene
Affected at Risk (%) Affected at Risk (%) Affected at Risk (%) Affected at Risk (%) Affected at Risk (%) Affected at Risk (%)
Total 0/4 (0.00%) 0/4 (0.00%) 0/4 (0.00%) 0/4 (0.00%) 1/4 (25.00%) 0/4 (0.00%)
Infections and infestations
Lyme Disease 0 /4 (0.00%) 0 /4 (0.00%) 0 /4 (0.00%) 0 /4 (0.00%) 1 /4 (25.00%) 0 /4 (0.00%)
Total
Total, serious adverse events 0 /4 (0.00%) 0 /4 (0.00%) 0 /4 (0.00%) 0 /4 (0.00%) 1 /4 (25.00%) 0 /4 (0.00%)
Show Other (Not Including Serious) Adverse Events
  Anastrazole-clomiphene-placebo Anastrazole-placebo-clomiphene Clomiphene-anastrazole-placebo Clomiphene-placebo-anastrazole Placebo-clomiphene-anastrazole Placebo-anastrazole-clomiphene
Affected at Risk (%) Affected at Risk (%) Affected at Risk (%) Affected at Risk (%) Affected at Risk (%) Affected at Risk (%)
Total 2/4 (50.00%) 1/4 (25.00%) 1/4 (25.00%) 1/4 (25.00%) 1/4 (25.00%) 3/4 (75.00%)
Endocrine disorders
Decreased Libido 1 /4 (25.00%) 0 /4 (0.00%) 0 /4 (0.00%) 0 /4 (0.00%) 0 /4 (0.00%) 0 /4 (0.00%)
Weight Gain 0 /4 (0.00%) 0 /4 (0.00%) 0 /4 (0.00%) 0 /4 (0.00%) 1 /4 (25.00%) 0 /4 (0.00%)
Vitamin D deficiency 0 /4 (0.00%) 0 /4 (0.00%) 0 /4 (0.00%) 0 /4 (0.00%) 0 /4 (0.00%) 1 /4 (25.00%)
Gastrointestinal disorders
Bloated 1 /4 (25.00%) 0 /4 (0.00%) 0 /4 (0.00%) 0 /4 (0.00%) 0 /4 (0.00%) 0 /4 (0.00%)
General disorders
Fatigue 1 /4 (25.00%) 0 /4 (0.00%) 0 /4 (0.00%) 0 /4 (0.00%) 0 /4 (0.00%) 1 /4 (25.00%)
Insomnia 1 /4 (25.00%) 0 /4 (0.00%) 0 /4 (0.00%) 0 /4 (0.00%) 1 /4 (25.00%) 0 /4 (0.00%)
Nasal Septal Deviation 0 /4 (0.00%) 0 /4 (0.00%) 1 /4 (25.00%) 0 /4 (0.00%) 0 /4 (0.00%) 0 /4 (0.00%)
Headache 0 /4 (0.00%) 1 /4 (25.00%) 0 /4 (0.00%) 0 /4 (0.00%) 1 /4 (25.00%) 0 /4 (0.00%)
Infections and infestations
Ringworm 0 /4 (0.00%) 0 /4 (0.00%) 0 /4 (0.00%) 0 /4 (0.00%) 0 /4 (0.00%) 1 /4 (25.00%)
Upper Respiratory Infection (URI) 0 /4 (0.00%) 0 /4 (0.00%) 0 /4 (0.00%) 1 /4 (25.00%) 0 /4 (0.00%) 0 /4 (0.00%)
Musculoskeletal and connective tissue disorders
Right Big Toe Pain 0 /4 (0.00%) 0 /4 (0.00%) 1 /4 (25.00%) 0 /4 (0.00%) 0 /4 (0.00%) 0 /4 (0.00%)
Left Shoulder Pain 0 /4 (0.00%) 0 /4 (0.00%) 0 /4 (0.00%) 0 /4 (0.00%) 0 /4 (0.00%) 1 /4 (25.00%)
Rib Pain 1 /4 (25.00%) 0 /4 (0.00%) 0 /4 (0.00%) 0 /4 (0.00%) 0 /4 (0.00%) 0 /4 (0.00%)
Osteopenia 1 /4 (25.00%) 0 /4 (0.00%) 0 /4 (0.00%) 0 /4 (0.00%) 0 /4 (0.00%) 0 /4 (0.00%)
Nervous system disorders
Dizziness 0 /4 (0.00%) 0 /4 (0.00%) 0 /4 (0.00%) 0 /4 (0.00%) 0 /4 (0.00%) 1 /4 (25.00%)
Respiratory, thoracic and mediastinal disorders
Chronic Maxillary Sinusitis 0 /4 (0.00%) 0 /4 (0.00%) 1 /4 (25.00%) 0 /4 (0.00%) 0 /4 (0.00%) 0 /4 (0.00%)
Total
Total, other adverse events 2 /4 (50.00%) 1 /4 (25.00%) 1 /4 (25.00%) 1 /4 (25.00%) 1 /4 (25.00%) 3 /4 (75.00%)
Limitations and Caveats

[Not Specified]

More Information
Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact
  • Name/Title:Dr. Charles Welliver
  • Organization:Albany Medical Center
  • Phone:518-262-3341
  • EMail:wellivr@amc.edu
  • ClinicalTrials.gov Identifier: NCT03933618 History of Changes
  • Other Study ID Numbers: 4134
  • First Submitted: April 29, 2019
  • First Posted: May 1, 2019
  • Results First Submitted: July 15, 2019
  • Results First Posted: November 18, 2019
  • Last Update Posted: November 18, 2019