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

NCT05033743 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-02-05

Study results available
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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.

Conditions

  • Recurrent Bacterial Vaginosis

Interventions

DRUG

Secnidazole 2 GM Oral Granules

Once weekly 2g oral secnidazole for 18 weeks

Sponsors & Collaborators

  • Lupin Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Indiana University

    lead OTHER

Principal Investigators

  • Chemen Neal, MD · Assistant Professor

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-09
Primary Completion
2022-10-07
Completion
2022-10-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05033743 on ClinicalTrials.gov