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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.
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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

A Phase 3 Study of Solosec® for the Treatment of Trichomoniasis

Clinicaltrials.gov identifier NCT03935217

Recruitment Status Completed

First Posted May 2, 2019

Last update posted April 21, 2020

Study Description

Brief summary:

This is a Phase 3, multi-center, prospective, randomized, placebo-controlled, delayed treatment, double-blind, study to evaluate the effectiveness, and safety of a single, oral dose of Solosec® containing 2 grams of secnidazole in female patients with trichomoniasis.

  • Condition or Disease:Trichomonas Infection
  • Intervention/Treatment: Drug: Secnidazole
    Drug: Placebo
  • Phase: Phase 3
Detailed Description

The study will consist of a primary study phase (Visit 1 (baseline) to Visit 2 (Day 6-12)) and a follow-up phase (Visit 2 to Visit 3 (7-12 days post Visit 2)). During the primary phase patients will be randomly assigned in a 1:1 ratio to either Solosec or placebo. Patients will return to the clinic for the "test of cure" (TOC) visit to be conducted on Days 6-12 (Visit 2). After all Visit 2 study procedures have been completed, patients will receive the opposite treatment (placebo patients will receive Solosec and vice versa). Patients with V2 cultures that are subsequently positive for T. vaginalis will return to the clinic for Visit 3 (V3) assessments and investigator assessment of need for additional therapy (an additional Visit 4 may be scheduled at the investigator's discretion if culture at V3 is positive).

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 147 participants
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: A Phase 3, Multi-center, Prospective, Randomized, Placebo-Controlled, Delayed Treatment, Double-Blind Study to Evaluate the Effectiveness and Safety of a Single Oral Dose of Solosec® Granules Containing 2 Grams of Secnidazole for the Treatment of Trichomoniasis
  • Actual Study Start Date: April 2019
  • Actual Primary Completion Date: March 2020
  • Actual Study Completion Date: March 2020
Arms and interventions
Arm Intervention/treatment
Placebo Comparator: Placebo
Orally administered as a single dose with applesauce. Upon completion of primary phase patients will receive the opposite treatment (Solosec (containing 2 grams of secnidazole)
Drug: Secnidazole
Oral Granules containing secnidazole

Drug: Placebo
Oral Granules of placebo manufactured to mimic secnidazole
Experimental: Solosec (containing 2 grams of secnidazole)
Orally administered as a single dose with applesauce. Upon completion of primary phase patients will receive the opposite treatment (placebo)
Drug: Secnidazole
Oral Granules containing secnidazole

Drug: Placebo
Oral Granules of placebo manufactured to mimic secnidazole
Outcome Measures
  • Primary Outcome Measures: 1. Microbiological Cure [ Time Frame: Study Day 6-12 ]
    Vaginal Culture negative for T. vaginalis at TOC Visit
  • Other Outcome Measures: 1. Outcome Responders [ Time Frame: Study Day 6-12 ]
    Complete resolution of trichomoniasis symptoms (i.e. itching, discharge and odor recorded as normal) and vaginal culture result negative for T. vaginalis at TOC Visit
Eligibility Criteria
  • Ages Eligible for Study: 12 Years and older (Child, Adult, Older Adult)
  • Sexes Eligible for Study: Female
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- adult female or post-menarche adolescent girl ≥12 years of age in general good health

- Have a diagnosis of trichomoniasis at the screening visit as determined by one of the
following:

- positive T. vaginalis NAAT test within 30 days of screening for which treatment
has not been initiated.

- positive OSOM® rapid test.

- positive wet mount assessment.

- Agree to abstain from vaginal intercourse until the final study visit

- Agree not to have any vaginal penetration or use of any vaginal products for the
duration of the study

Exclusion Criteria:

- Are pregnant, lactating, or planning to become pregnant during the study.

- Are suspected clinically (or confirmed diagnostically) of having alternative causes of
vaginal symptoms including symptomatic vulvovaginal candidiasis, chlamydia, gonorrhea,
or an active genital herpes outbreak

- Are suspected clinically of having an acute urinary tract infection.

- Have active genital lesions, including primary syphilitic chancres and herpes simplex
virus lesions, or other vaginal or vulvar conditions which could confound the
interpretation of the clinical response, as determined by the Investigator (patients
with genital warts may be enrolled).

- Have received systemic antibacterial therapy or topical antimicrobial/antifungal/
immunomodulatory therapies in the genital area (vagina, vulva and surrounding soft
tissue), within 14 days prior to the Baseline Visit (Day 1).

Contacts and Locations
Contacts
Locations
Show 11 Study Locations
Sponsors and Collaborators

Lupin Research Inc

Investigators

Study Director: Jackie Shaw Director, Clinical Operations

More Information
  • Responsible Party: Lupin Research Inc
  • ClinicalTrials.gov Identifier: NCT03935217 History of Changes
  • Other Study ID Numbers: SEC-WH-301
  • First Posted: May 2, 2019 Key Record Dates
  • Last Update Posted: April 21, 2020
  • Last Verified: April 2020
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Lupin Research Inc: Vaginal Discharge Vaginal Itching
  • Additional relevant MeSH terms: Trichomonas Infections