Clinical trial NCT03935217: A Phase 3 Study of Solosec® for the Treatment of Trichomoniasis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Trichomonas Infection
Keywords: Vaginal Itching
Vaginal Discharge
Lead sponsor: Lupin Research Inc
Sponsor class: INDUSTRY
First posted: 2019-05-02
Enrollment: 147
Sex: FEMALE
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: For primary phase of study, patients were randomly assigned in a 1:1 ratio to either Solosec or Placebo.
Primary purpose: TREATMENT

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

Eligibility 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).

Primary outcomes:
measure: Microbiological Cure at the TOC Visit
timeFrame: Study Day 6-12
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Site 1007
state: Alabama
city: North Miami
country: United States
facility: Site 1003
state: Florida
city: Chicago
country: United States
facility: Site 1014
state: Illinois
city: Jackson
country: United States
facility: Site 1013
state: Mississippi
city: Lawrenceville
country: United States
facility: Site 1009
state: New Jersey
city: Chapel Hill
country: United States
facility: Site 1008
state: North Carolina
city: Fayetteville
country: United States
facility: Site 1004
state: North Carolina
city: Charleston
country: United States
facility: Site 1011
state: South Carolina
city: Memphis
country: United States
facility: Site 1001
state: Tennessee
city: Memphis
country: United States
facility: Site 1002
state: Tennessee
city: Virginia Beach
country: United States
facility: Site 1006
state: Virginia
Study officials:
affiliation: Director, Clinical Operations
name: Jackie Shaw
role: STUDY_DIRECTOR
References:
citation: Muzny CA, Schwebke JR, Nyirjesy P, Kaufman G, Mena LA, Lazenby GB, Van Gerwen OT, Graves KJ, Arbuckle J, Carter BA, McMahon CP, Eder S, Shaw J, Pandey B, Chavoustie SE. Efficacy and Safety of Single Oral Dosing of Secnidazole for Trichomoniasis in Women: Results of a Phase 3, Randomized, Double-Blind, Placebo-Controlled, Delayed-Treatment Study. Clin Infect Dis. 2021 Sep 15;73(6):e1282-e1289. doi: 10.1093/cid/ciab242.