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

Recruiting now · Phase 4

Conditions studied: Trichomonas Vaginitis, Bacterial Vaginitis

In brief

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.

Key facts

Study ID

NCT06261840

Run by

Tulane University

People needed

1200

Starts

2025-05-06

Expected to finish

2029-07-31

Last updated by the study team

2026-05-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham [UAB] Gynecology Clinics — Birmingham, Alabama, United States (enrolling)
• UAB Sexual Health Research Clinic [SHRC] — Birmingham, Alabama, United States (enrolling)
• LSU-CrescentCare Sexual Health Center — New Orleans, Louisiana, United States (enrolling)
• Segal Trials Healthcare Clinical Data, Inc. 1065 NE 125th St. Suite 417 North Miami, FL 33161 — North Miami, Florida, United States

Full record on ClinicalTrials.gov

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