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

• Status: Completed
• Trial end date: 2020-03-18
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lupin Research Inc
• Treatments: Metronidazole; Secnidazole

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).