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Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05033743
Study type Interventional
Source Indiana University
Contact Graham A Hogg
Phone 3179620415
Email [email protected]
Status Recruiting
Phase Phase 2/Phase 3
Start date July 9, 2021
Completion date June 2022

See also
  Status Clinical Trial Phase
Not yet recruiting NCT04046900 - Vaginal Microbiota Transplant Phase 1/Phase 2
Completed NCT02209519 - Randomized Controlled Trial of Treatment of Male Partners of Women With BV Phase 3
Withdrawn NCT00324142 - A Pilot Study of Oral Tinidazole for Women With Recurrent Bacterial Vaginosis Phase 2