Trichomonas Infection Clinical Trial
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
Verified date | September 2023 |
Source | Lupin Research Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 147 |
Est. completion date | March 25, 2020 |
Est. primary completion date | March 2, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 12 Years and older |
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 OSOMĀ® 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). |
Country | Name | City | State |
---|---|---|---|
United States | Site 1007 | Birmingham | Alabama |
United States | Site 1008 | Chapel Hill | North Carolina |
United States | Site 1011 | Charleston | South Carolina |
United States | Site 1014 | Chicago | Illinois |
United States | Site 1004 | Fayetteville | North Carolina |
United States | Site 1013 | Jackson | Mississippi |
United States | Site 1009 | Lawrenceville | New Jersey |
United States | Site 1001 | Memphis | Tennessee |
United States | Site 1002 | Memphis | Tennessee |
United States | Site 1003 | North Miami | Florida |
United States | Site 1006 | Virginia Beach | Virginia |
Lead Sponsor | Collaborator |
---|---|
Lupin Research Inc |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Microbiological Cure at the TOC Visit | Vaginal Culture negative for T. vaginalis at TOC Visit | Study Day 6-12 |