Trichomonas VaginitisPhase 4NCT06261840
Refining Treatment Options for Trichomonas Vaginalis Infection: A Comparative Analysis of Metronidazole and Secnidazole
A Phase 4 study testing Metronidazole 500 mg and Secnidazole 2000 MG in people with Trichomonas Vaginitis and Bacterial Vaginitis, run by Tulane University at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Trichomonas Vaginitis, Bacterial Vaginitis
- What is being tested?
- Metronidazole 500 mg and Secnidazole 2000 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 4 sitesUnited States
- Study dates
- 6 May 2025to 31 Jul 2029
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
University of Alabama at Birmingham [UAB] Gynecology Clinics
Birmingham, Alabama, 25233
Stephanie Clevenger, 205-934-0877, slangan@uabmc.edu
Janeen Arbuckle
- Recruiting
UAB Sexual Health Research Clinic [SHRC]
Birmingham, Alabama, 35205
Saralyn Richter, 205-934-8166, srichter@uabmc.edu
Christina Muzny
- Recruiting
LSU-CrescentCare Sexual Health Center
New Orleans, Louisiana, 70119
Catherine Cammarata, 504-568-4132, CCamma@lsuhsc.edu
Rebecca Lillis
- Not yet recruiting
Segal Trials Healthcare Clinical Data, Inc. 1065 NE 125th St. Suite 417 North Miami, FL 33161
North Miami, Florida, 33161
Dimary Rivera, 305-722-8444, drivera@segaltrials.com
Steven Chavoustie
About this study
Official title: Refining Treatment Options for Trichomonas Vaginalis Infection in Women and Men: A Comparative Analysis of Oral Multi-Dose Metronidazole and Single-Dose Secnidazole
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.
Read the detailed description
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. The goal is to refine T. vaginalis treatment for women and men by examining the effectiveness (Aim 1) and cost-effectiveness (Aim 2) of multi-dose oral MTZ versus single-dose oral SEC. The investigators have several secondary analyses for Aim 1 including to examine if bacterial vaginosis (BV) interferes with T. vaginalis treatment, to explore preferences for follow-up visits, and to examine the natural history of T. vaginalis infection in both sexes.
If single-dose oral SEC is found to be superior to multi-dose oral MTZ, this could potentially result in an estimated 280,000 people in the U.S./year receiving better care, having fewer adverse sexual and reproductive health outcomes, and having a reduced risk for HIV acquisition. It will also provide patients with a single-dose oral treatment option that will be particularly attractive for subjects with concomitant T. vaginalis and BV.
- Conditions
- Trichomonas Vaginitis, Bacterial Vaginitis
- Being tested
- Metronidazole 500 mg, Secnidazole 2000 MG
- Medical subject headings
- Trichomonas Vaginitis, Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metronidazole 500 mgDrug
Also called FLAGYL
Multi-dose oral MTZ (500 mg twice daily for 7 days) for the treatment of T. vaginalis infection in women and men
Secnidazole 2000 MGDrug
Also called SOLOSEC
Single-dose 2 g oral SEC for the treatment of T. vaginalis infection in women and men
| Study group | Role | What they receive |
|---|---|---|
| Oral Multi-Dose Metronidazole | Experimental | Multi-dose oral MTZ (500 mg twice daily for 7 days) for the treatment of T. vaginalis infection in women and men Receives: Drug: Metronidazole 500 mg |
| Single-Dose Secnidazole | Experimental | Single-dose 2 g oral SEC for the treatment of T. vaginalis infection in women and men Receives: Drug: Secnidazole 2000 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment, as Measured by the Number of Participants that are Cured of Trichomonas Vaginalis at one month test of cure.
A repeat T. vaginalis NAAT test will be completed at the test of cure (TOC) visit
Measured: A TOC visit will be scheduled 4 weeks (+- 1 week) after post completion of treatment
Secondary outcomes (4)
To examine if BV co-infection interferes with T. vaginalis treatment
Of those who test positive for BV via BV OSOM at baseline, those who re-test positive via BV OSOM at one-month test-of-cure will be compared by treatment arm.
Measured: From enrollment to completion of one-month test of cure for those who test BV positive at baseline.
To examine if oral single-dose secnidazole is superior to oral multi-dose metronidazole for the treatment of BV.
We will conduct a secondary analysis to compare the effectiveness of oral single-dose secnidazole versus oral multi-dose metronidazole among women enrolled in the trial with a diagnosis of BV at baseline. Those who test positive for BV via BV OSOM at baseline will be re-tested and BV positivity at one-month will be compared by treatment arm.
Measured: From baseline visit to one-month test of cure visit
A comparison of participant preferences for the test-of-cure (TOC) visit (in clinic versus telemedicine) as captured on baseline survey.
Participants will be asked their preference for an in person one-month test of cure visit that is in person versus telehealth.
Measured: From baseline visit to one-month test of cure visit
A comparison of TV NAAT confirmatory test results to determine the percentage who spontaneously clear the infection without medication.
Women and men who previously tested positive for T. vaginalis by nucleic acid amplification test (NAAT) will be retested by NAAT at study entry. The rate of early spontaneous resolution will be calculated.
Measured: at baseline, we document their prior test result (per medical records, survey or onsite testing).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start6 May 2025
- Primary completion1 May 2029 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Trichomonas VaginitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tulane University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alabama at Birmingham, Louisiana State University Health Sciences Center in New Orleans, Healthcare Clinical Data
- Responsible party
- Principal investigator, Patricia Kissinger, Tulane University
- Investigators
- Patricia Kissinger, PhD, Principal investigator, Tulane University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06261840
- Sponsor's protocol ID
- 2024-101
- Status last verified
- May 2026
- First submitted
- 7 Feb 2024
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Muzny CA, Lillis RA, Chavoustie SE, Arbuckle JL, Van Gerwen OT, Sagoe M, Kandregula AR, Srivastav S, Kissinger PJ. Refining Trichomonas vaginalis treatment in women and men: protocol for an open-label randomised comparison of multi-dose oral metronidazole versus single-dose oral secnidazole. BMJ Open. 2026 Apr 24;16(4):e116003. doi: 10.1136/bmjopen-2025-116003.
PubMed 42031495