Actively Recruiting

Phase 4
Age: 18Years +
All Genders
Healthy Volunteers
NCT06261840

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

Led by Tulane University · Updated on 2026-05-06

1200

Participants Needed

4

Research Sites

221 weeks

Total Duration

On this page

Sponsors

T

Tulane University

Lead Sponsor

U

University of Alabama at Birmingham

Collaborating Sponsor

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Women and men aged 18 years or older of any race or ethnicity
  • Positive diagnosis of Trichomonas vaginalis by rapid antigen test, wet mount microscopy, nucleic acid amplification test (NAAT), or Pap smear within two weeks prior to enrollment
  • Confirmation of Trichomonas vaginalis infection by repeat NAAT testing at study entry
  • Ability and willingness to provide informed consent and comply with study procedures
  • Access to a method of contact such as phone, email, or social media
  • Willingness to be randomly assigned to treatment groups
Not Eligible

You will not qualify if you...

  • Pregnant, lactating, or planning to become pregnant
  • Treatment with 5-nitroimidazole medications (metronidazole, tinidazole, or secnidazole) within the past 28 days
  • Use of intravaginal boric acid or other intravaginal treatments for Trichomonas vaginalis within the past 14 days
  • History of type 1 hypersensitivity reaction to 5-nitroimidazole drugs
  • Current use of phenytoin (Dilantin) or warfarin (Coumadin) due to possible drug interactions with metronidazole
  • Use of medications affecting metronidazole metabolism such as lithium or barbiturates (amobarbital, butalbital, methohexital, phenobarbital, pentobarbital, primidone, secobarbital)
  • Previous participation in this study

AI-Screening

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Trial Site Locations

Total: 4 locations

1

University of Alabama at Birmingham [UAB] Gynecology Clinics

Birmingham, Alabama, United States, 25233

Actively Recruiting

2

UAB Sexual Health Research Clinic [SHRC]

Birmingham, Alabama, United States, 35205

Actively Recruiting

3

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

North Miami, Florida, United States, 33161

Not Yet Recruiting

4

LSU-CrescentCare Sexual Health Center

New Orleans, Louisiana, United States, 70119

Actively Recruiting

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Research Team

P

Patricia Kissinger, PhD

CONTACT

C

Christina Muzny, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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