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

Last updated: May 4, 2026
Sponsor: Tulane University
Overall Status: Active - Recruiting

Phase

4

Condition

Vaginitis

Vaginal Infection

Treatment

Metronidazole 500 mg

Secnidazole 2000 MG

Clinical Study ID

NCT06261840
2024-101
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Women and men aged 18 years or older of any race/ethnicity will be included in thestudy.

  • Participants must have either a positive T. vaginalis rapid antigen test (OSOM), orwet mount microscopy with motile trichomonads, or nucleic acid amplification test (NAAT) urinalysis or Pap smear positive for TV within two weeks of available results (and have not yet been treated) that is confirmed by repeat T. vaginalis NAATtesting at study enrollment,

  • Willing and able to provide and understand informed consent to comply with the studyprotocol,

  • Have a method of contact (either phone, email or social media),

  • Be willing to be randomized.

Exclusion

Exclusion Criteria:

  • Pregnant/lactating or seeking to be pregnant

  • Have been treated for with a 5-nitroimidazole (i.e. Metronidazole (MTZ), tinidazole (TDZ), or secnidazole [SEC]) in the last 28 days

  • Used intravaginal boric acid or any other intravaginal treatment for T. vaginalis inthe last 14 days

  • Have a history of a type 1 hypersensitivity reaction to 5-nitroimidazole medications

  • Are taking phenytoin (Dilantin) and/or warfarin (Coumadin) due to drug-druginteractions with oral MTZ

  • Use of medications which may alter the metabolism of MTZ including Lithium andbarbiturates (amobarbital, butalbital, methohexital, phenobarbital, pentobarbital,primidone, secobarbital)

  • Have been previously enrolled in the study

Study Design

Total Participants: 1200
Treatment Group(s): 2
Primary Treatment: Metronidazole 500 mg
Phase: 4
Study Start date:
May 06, 2025
Estimated Completion Date:
July 31, 2029

Study Description

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. The goal is to refine T. vaginalis treatment for women and men by examining the effectiveness (Aim 1) and cost-effectiveness (Aim 2) of multi-dose oral MTZ versus single-dose oral SEC. The investigators have several secondary analyses for Aim 1 including to examine if bacterial vaginosis (BV) interferes with T. vaginalis treatment, to explore preferences for follow-up visits, and to examine the natural history of T. vaginalis infection in both sexes.

If single-dose oral SEC is found to be superior to multi-dose oral MTZ, this could potentially result in an estimated 280,000 people in the U.S./year receiving better care, having fewer adverse sexual and reproductive health outcomes, and having a reduced risk for HIV acquisition. It will also provide patients with a single-dose oral treatment option that will be particularly attractive for subjects with concomitant T. vaginalis and BV.

Connect with a study center

  • UAB Sexual Health Research Clinic [SHRC]

    Birmingham, Alabama 35205
    United States

    Active - Recruiting

  • University of Alabama at Birmingham [UAB] Gynecology Clinics

    Birmingham, Alabama 25233
    United States

    Active - Recruiting

  • Segal Trials Healthcare Clinical Data, Inc. 1065 NE 125th St. Suite 417 North Miami, FL 33161

    North Miami, Florida 33161
    United States

    Site Not Available

  • LSU-CrescentCare Sexual Health Center

    New Orleans, Louisiana 70119
    United States

    Active - Recruiting

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