Actively Recruiting
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
Eligibility Criteria
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
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
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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