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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT03935217

Public ClinicalTrials.gov record NCT03935217. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 8:44 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT03935217
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Lupin Research Inc
Industry
Enrollment
147 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
12 Years and older
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 23, 2019 (Actual)
Primary completion
Mar 2, 2020 (Actual)
Completion
Mar 25, 2020 (Actual)
Last update posted
Oct 4, 2023

2019 – 2020

United States locations

U.S. sites
11
U.S. states
9
U.S. cities
10
Facility City State ZIP Site status
Site 1007 Birmingham Alabama 35294 —
Site 1003 North Miami Florida 33161 —
Site 1014 Chicago Illinois 60605 —
Site 1013 Jackson Mississippi 39216 —
Site 1009 Lawrenceville New Jersey 08648 —
Site 1008 Chapel Hill North Carolina 27599 —
Site 1004 Fayetteville North Carolina 28304 —
Site 1011 Charleston South Carolina 29425 —
Site 1001 Memphis Tennessee 38104 —
Site 1002 Memphis Tennessee 38120 —
Site 1006 Virginia Beach Virginia 23456 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03935217, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 4, 2023 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03935217 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →