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

Study Overview
=================
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.

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). To ensure all patients receive treatment and to maintain the double-blind, after completion of the primary phase, 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). Summary of results includes data reported during the primary phase of the study [Visit 1 (baseline) to Visit 2/TOC (Day 6-12)]

Official Title
-----------------
Multi-center, Prospective, Randomized, Placebo-Controlled, Delayed Treatment, Double-Blind Study to Evaluate the Effectiveness and Safety of a Single Oral Dose of Solosec® for the Treatment of Trichomoniasis

Conditions
-----------------
Trichomonas Infection

Intervention / Treatment
-----------------
* Drug: Secnidazole
* Drug: Placebo


Participation Criteria
=================
Eligibility 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).

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: For primary phase of study, patients were randomly assigned in a 1:1 ratio to either Solosec or Placebo.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Solosec (containing 2 grams of secnidazole)<br>Orally administered as a single dose with applesauce. | Drug: Secnidazole<br>* Oral Granules containing secnidazole<br>* Other names: Solosec®;|
| Placebo Comparator: Placebo<br>Orally administered as a single dose with applesauce. | Drug: Placebo<br>* Oral Granules of placebo manufactured to mimic secnidazole<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiological Cure at the TOC Visit | Vaginal Culture negative for T. vaginalis at TOC Visit | Study Day 6-12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vaginal Itching, Vaginal Discharge