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

Conditions

• Bacterial Vaginitis
• Trichomonas Vaginitis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Metronidazole 500 mg — DRUG
  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 — DRUG
  Single-dose 2 g oral SEC for the treatment of T. vaginalis infection in women and men

Study Details

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 Dates

Start date

May 6, 2025

Status verified

May 2026

Primary completion

May 1, 2029

Completion

Jul 31, 2029

Study Design

Enrollment

1,200 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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

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

• Patricia Kissinger, PhD
  504-988-7320
  [email protected]
• Christina Muzny, MD
  205-975-3298
  [email protected]

Locations (4)

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