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

Indiana University

Status and phase

Completed

Phase 3

Phase 2

Conditions

Recurrent Bacterial Vaginosis

Treatments

Drug: Secnidazole 2 GM Oral Granules

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05033743

10283

Details and patient eligibility

About

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.

Full description

A single-center prospective pilot study with once-weekly oral secnidazole granule treatment of acute condition for two-weeks followed by prophylactic treatment of asymptomatic responders with once-weekly secnidazole for 16 weeks, followed by no therapy for 12 weeks. The final follow-up evaluation is at week 28.

Eligible women with a current symptomatic bacterial vaginosis infection (> or = 3 Amsel criteria) and a history of at least 2 previous episodes of bacterial vaginosis in the past year will be enrolled in the open-label treatment study. All women will be treated with 2g of secnidazole granules orally once-weekly for 2 weeks. At the second visit, 3-5 days after completion of treatment, women who have a resolution of bacterial vaginosis (asymptomatic and < or = 2 Amsel criteria) will continue on once-weekly secnidazole for 16 weeks.

Patients will be evaluated every 4 weeks for recurrence of bacterial vaginosis. This will include questions about symptoms as well as a pelvic examination for assessment of vaginal discharge (> or = 3 Amsel criteria). We will also collect any information on other clinical evaluations for recurrence and the dates of diagnoses and types of treatments they may have received. Those who remain without recurrence during the 16-week suppressive phase will be followed for an additional 12 weeks off therapy, with assessment for recurrence at weeks 22 and 30. Throughout the study, data will be collected on participants' compliance and on the occurrence of adverse events.

Enrollment

24 patients

Sex

Female

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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.