Recruiting

MTZ vs. SEC

Sponsor:

Tulane University

Code:

NCT06261840

Conditions

Trichomonas Vaginitis

Bacterial Vaginitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Metronidazole 500 mg

Secnidazole 2000 MG

Study Details

Brief 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

Study ID

NCT06261840

Start date

May 6, 2025

Status verified date

May, 2026

Completion date

Jul 31, 2029

Anticipated

Primary completion date

May 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

1200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Oral Multi-Dose Metronidazole

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

experimental: Single-Dose Secnidazole

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

Interventions

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

Secnidazole 2000 MG

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

Primary outcome measure

  • Treatment, as Measured by the Number of Participants that are Cured of Trichomonas Vaginalis at one month test of cure. [ Time Frame: A TOC visit will be scheduled 4 weeks (+- 1 week) after post completion of treatment ]

Central Contacts and Locations

Central contacts

Patricia Kissinger, PhD

504-988-7320kissing@tulune.edu

Christina Muzny, MD

205-975-3298cmuzny@uabmc.edu

Locations

University of Alabama at Birmingham [UAB] Gynecology Clinics

Recruiting

Birmingham, Alabama, United States, 25233

Contacts

Stephanie Clevenger

205-934-0877slangan@uabmc.edu

UAB Sexual Health Research Clinic [SHRC]

Recruiting

Birmingham, Alabama, United States, 35205

Contacts

Saralyn Richter

205-934-8166srichter@uabmc.edu

Principal Investigator:

Christina Muzny

LSU-CrescentCare Sexual Health Center

Recruiting

New Orleans, Louisiana, United States, 70119

Contacts

Catherine Cammarata

504-568-4132CCamma@lsuhsc.edu

More Information

Sponsor

Tulane University

Last update posted

May 6, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Tulane University on 2026-05-06.