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Refining Treatment Options for Trichomonas Vaginalis Infection: A Comparative Analysis of Metronidazole and Secnidazole

NCT06261840 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1200

Last updated 2026-05-06

No results posted yet for this study

Summary

This is a multi-centered, randomized, open-label, parallel, phase IV clinical trial comparing the effectiveness and cost-effectiveness of oral multi-dose metronidazole (MTZ) and oral single-dose secnidazole (SEC) for the treatment of Trichomonas vaginalis in both women and men.

Conditions

  • Trichomonas Vaginitis
  • Bacterial Vaginitis

Interventions

DRUG

Metronidazole 500 mg

Multi-dose oral MTZ (500 mg twice daily for 7 days) for the treatment of T. vaginalis infection in women and men

DRUG

Secnidazole 2000 MG

Single-dose 2 g oral SEC for the treatment of T. vaginalis infection in women and men

Sponsors & Collaborators

  • University of Alabama at Birmingham

    collaborator OTHER

  • Louisiana State University Health Sciences Center in New Orleans

    collaborator OTHER

  • Healthcare Clinical Data

    collaborator UNKNOWN

  • Tulane University

    lead OTHER

Principal Investigators

  • Patricia Kissinger, PhD · Tulane University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-06
Primary Completion
2029-05-01
Completion
2029-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT06261840 on ClinicalTrials.gov