NCT03935217

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 147 (actual)
• Sponsor: Lupin Research Inc · Industry
• Sex: Female
• Age: 12 Years
• Healthy volunteers: Not accepted

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

Conditions

• Trichomonas Infection

Interventions

Type	Name	Description
DRUG	Secnidazole	Oral Granules containing secnidazole
DRUG	Placebo	Oral Granules of placebo manufactured to mimic secnidazole

Timeline

• Start date: 2019-04-23
• Primary completion: 2020-03-02
• Completion: 2020-03-25
• First posted: 2019-05-02
• Last updated: 2023-10-04
• Results posted: 2023-10-04

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study