Suppressive Antibacterial Therapy With Once-Weekly Secnidazole Granules to Prevent Recurrent Bacterial Vaginosis; A Pilot Study

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to test the effectiveness Secnidazole to treat recurrent BV. Secnidazole is approved for one-time use in acute BV. In this study, the drug will be used for recurrent BV, and given weekly for 18 weeks.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Indiana University
• Collaborator: Lupin Pharmaceuticals, Inc.
• Treatments: Secnidazole

Criteria

Inclusion Criteria:

• Ability to consent in English

• Current symptomatic bacterial vaginosis infection

• History of at least 2 previous episodes of bacterial vaginosis in the past year

Exclusion Criteria:

• Current gynecologic infection or condition, including candida vaginitis, gonorrhea, chlamydia, trichomonas, desquamative inflammatory vaginitis, atrophic vaginitis.

• Pre-existing heart conditions

• Pre-existing neurological conditions

• Currently Pregnant or breastfeeding

• Women taking anticoagulants, lithium, metoclopramide, or disulfiram therapy

• Hypersensitivity to secnidazole or other drugs in the same class.