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

RecruitingPhase 4Healthy volunteers welcome

Refining Treatment Options for Trichomonas Vaginalis Infection in Women and Men: A Comparative Analysis of Oral Multi-Dose Metronidazole and Single-Dose Secnidazole

Who can join

Ages 18 and older · All sexes · Healthy volunteers welcome

Full eligibility 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

About the study

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.

What is being tested

Sponsor: Tulane University · Participants: 1,200 · Started: May 6, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06261840

Locations in the U.S.

AlabamaUAB Sexual Health Research Clinic [SHRC], Birmingham
University of Alabama at Birmingham [UAB] Gynecology Clinics, Birmingham
FloridaSegal Trials Healthcare Clinical Data, Inc. 1065 NE 125th St. Suite 417 North Miami, FL 33161, North Miami (Not yet recruiting)
LouisianaLSU-CrescentCare Sexual Health Center, New Orleans

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.