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

NCT03935217 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 147

Last updated 2023-10-04

Study results available
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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.

Conditions

  • Trichomonas Infection

Interventions

DRUG

Secnidazole

Oral Granules containing secnidazole

DRUG

Placebo

Oral Granules of placebo manufactured to mimic secnidazole

Sponsors & Collaborators

  • Lupin Research Inc

    lead INDUSTRY

Principal Investigators

  • Jackie Shaw · Director, Clinical Operations

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-23
Primary Completion
2020-03-02
Completion
2020-03-25
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03935217 on ClinicalTrials.gov