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RecruitingAccepts healthy volunteersPhase 4

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

Tulane University · with University of Alabama at Birmingham, Louisiana State University Health Sciences Center in New Orleans · NCT06261840

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 4
Target enrollment
1200
US sites recruiting
3
Study start
May 6, 2025
Record last updated
May 6, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Metronidazole 500 mg; Secnidazole 2000 MG

Conditions: Trichomonas Vaginitis; Bacterial Vaginitis

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • Women and men aged 18 years or older of any race/ethnicity will be included in the study.
  • Participants must have either a positive T. vaginalis rapid antigen test (OSOM), or wet 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 NAAT testing at study enrollment,
  • Willing and able to provide and understand informed consent to comply with the study protocol,
  • Have a method of contact (either phone, email or social media),
  • Be willing to be randomized.

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 in the 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-drug interactions with oral MTZ
  • Use of medications which may alter the metabolism of MTZ including Lithium and barbiturates (amobarbital, butalbital, methohexital, phenobarbital, pentobarbital, primidone, secobarbital)
  • Have been previously enrolled in the study

Recruiting US locations

  • University of Alabama at Birmingham [UAB] Gynecology Clinics

    Birmingham, AL 25233

    Site contact: Stephanie Clevenger · 205-934-0877 · slangan@uabmc.edu

  • UAB Sexual Health Research Clinic [SHRC]

    Birmingham, AL 35205

    Site contact: Saralyn Richter · 205-934-8166 · srichter@uabmc.edu

  • LSU-CrescentCare Sexual Health Center

    New Orleans, LA 70119

    Site contact: Catherine Cammarata · 504-568-4132 · CCamma@lsuhsc.edu

Study contacts (from the official record)

  • Patricia Kissinger, PhD · 504-988-7320 · kissing@tulune.edu
  • Christina Muzny, MD · 205-975-3298 · cmuzny@uabmc.edu
All women’s health studies in Alabama →
Refining Treatment Options for Trichomonas Vaginalis Infection: A… (NCT06261840) | Bored Studies