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

Phase 3

Completed

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 \[Visit 1 (baseline) to Visit 2/TOC (Day 6-12)\]

Recruitment & Eligibility

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).

Arm && Interventions

Group	Intervention	Description
Solosec (containing 2 grams of secnidazole)	Secnidazole	Orally administered as a single dose with applesauce.
Placebo	Placebo	Orally administered as a single dose with applesauce.

Primary Outcome Measures

Name	Time	Method
Microbiological Cure at the TOC Visit	Study Day 6-12	Vaginal Culture negative for T. vaginalis at TOC Visit

Secondary Outcome Measures

Name	Time	Method

Locations (11): Site 1006
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Virginia Beach, Virginia, United States
Site 1007
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Birmingham, Alabama, United States
Site 1011
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Charleston, South Carolina, United States
Site 1013
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Jackson, Mississippi, United States
Site 1003
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North Miami, Florida, United States
Site 1009
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Lawrenceville, New Jersey, United States
Site 1008
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Chapel Hill, North Carolina, United States
Site 1004
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Fayetteville, North Carolina, United States
Site 1002
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Memphis, Tennessee, United States
Site 1001
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Memphis, Tennessee, United States
Site 1014
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Chicago, Illinois, United States