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