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Anti-infective Agent

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

Phase 2 & 3
Waitlist Available
Led By Chemen Neal, MD
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 210 days (30 weeks)
Awards & highlights
No Placebo-Only Group

Summary

This trial tests if taking secnidazole regularly can help women with recurrent bacterial vaginosis. Secnidazole is a medication that kills the bacteria causing the infection. The study aims to see if regular doses can prevent the infection from returning. Secnidazole has been studied for its effectiveness in treating bacterial vaginosis, as it is an alternative to the commonly used metronidazole.

Eligible Conditions
  • Bacterial Vaginosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~210 days (30 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 210 days (30 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Subjects With at Least One Episode of Bacterial Vaginosis
Probability of Failure at 210 Days
The Number of Subjects That Failed Treatment in the Supressive Phase
Secondary study objectives
Number of Subjects Who Experienced Recurrence 10 Weeks After Start of Initial Treatment
Number of Subjects Who Experienced Recurrence 14 Weeks After Start of Initial Treatment
Number of Subjects Who Experienced Recurrence 18 Weeks After Start of Initial Treatment
+4 more
Other study objectives
Number of Adverse Events
Number of Participant With Compliance
Number of Participants With Tolerance

Side effects data

From 2022 Phase 2 & 3 trial • 24 Patients • NCT05033743
29%
Yeast Infection
8%
Headache
8%
Loose Stool
8%
UTI
4%
left lower quadrent pain
4%
COVID-19 infection
4%
Nausea
4%
spotting
4%
urinary odor
4%
Post Operative Pulmonary Embolism
4%
change in discharge
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment Group

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment GroupExperimental Treatment1 Intervention
Secnidazole treatment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Secnidazole 2 GM Oral Granules
2021
Completed Phase 3
~30

Find a Location

Who is running the clinical trial?

Lupin Pharmaceuticals, Inc.Industry Sponsor
1 Previous Clinical Trials
24,258 Total Patients Enrolled
Indiana UniversityLead Sponsor
1,045 Previous Clinical Trials
1,316,860 Total Patients Enrolled
Chemen Neal, MDPrincipal InvestigatorAssistant Professor
~5 spots leftby Dec 2025
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