Phase 3
Completed N=24
Suppressive Antibacterial Therapy With Once-Weekly Secnidazole Granules to Prevent Recurrent Bacterial Vaginosis; A Pilot Study
Recurrent Bacterial Vaginosis
Source: ClinicalTrials.gov NCT05033743 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcomePrimary: Number of Subjects With at Least One Episode of Bacterial Vaginosis — 8 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With at Least One Episode of Bacterial Vaginosis |
8 | — |
| PRIMARY Probability of Failure at 210 Days |
0.7051 | — |
| PRIMARY The Number of Subjects That Failed Treatment in the Supressive Phase |
3 | — |
| SECONDARY Number of Subjects Who Experienced Recurrence 3-5 Days After Initial Treatment (Initial Treatment Was 2 Weeks Long) |
5 | — |
| SECONDARY Number of Subjects Who Experienced Recurrence 6 Weeks After Start of Initial Treatment |
— | — |
| SECONDARY Number of Subjects Who Experienced Recurrence 10 Weeks After Start of Initial Treatment |
— | — |
| SECONDARY Number of Subjects Who Experienced Recurrence 14 Weeks After Start of Initial Treatment |
1 | — |
| SECONDARY Number of Subjects Who Experienced Recurrence 18 Weeks After Start of Initial Treatment |
1 | — |
| SECONDARY Number of Subjects Who Experienced Recurrence 22 Weeks After Start of Initial Treatment |
2 | — |
| SECONDARY Number of Subjects Who Experienced Recurrence 30 Weeks After Start of Initial Treatment |
3 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT05033743). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.