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

NCT05033743 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 10283
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Number of Subjects With at Least One Episode of Bacterial Vaginosis

  Overall failure rate as measured by the number of subjects with at least one episode of bacterial vaginosis in the 30 week follow-up period.

  30 weeks

• Probability of Failure at 210 Days

  To assess the efficacy of secnidazole, we estimated failure rates and 95% exact confidence intervals for initial treatment, suppression therapy following initial resolution of BV symptoms, and overall. For the time-to-failure analysis, time was defined as the number of days since the second visit where clinical resolution of initial BV was confirmed. The non-parametric maximum likelihood estimate (NPMLE) of the survival curve was estimated using the interval package in R to account for the interval censored data. Results are presented using an Amsel criteria score of as well as for BV diagnosis. All analyses were conducted using R 4.2.2 (R Core Team, 2020) in RStudio (RStudio Team 2021).

  210 days (30 weeks)

• The Number of Subjects That Failed Treatment in the Supressive Phase

  The probability of recurrence or treatment failure was calculated as time from the second visit in days. This timeframe is the suppressive therapy phase and was 30 weeks long.

  30 weeks

Secondary Outcomes (7)

• Number of Subjects Who Experienced Recurrence 3-5 Days After Initial Treatment (Initial Treatment Was 2 Weeks Long)

  3-5 days after initial treatment after initial treatment of 2 weeks

• Number of Subjects Who Experienced Recurrence 6 Weeks After Start of Initial Treatment

  week 6

• Number of Subjects Who Experienced Recurrence 10 Weeks After Start of Initial Treatment

  week 10

• Number of Subjects Who Experienced Recurrence 14 Weeks After Start of Initial Treatment

  week 14

• Number of Subjects Who Experienced Recurrence 18 Weeks After Start of Initial Treatment

  week 18

Other Outcomes (3)

• Number of Participant With Compliance

  18 weeks

• Number of Participants With Tolerance

  18 weeks

• Number of Adverse Events

  30 weeks

Study Arms (1)

Treatment Group

EXPERIMENTAL

Secnidazole treatment

Drug: Secnidazole 2 GM Oral Granules

Interventions

Secnidazole 2 GM Oral Granules DRUG

Once weekly 2g oral secnidazole for 18 weeks

Treatment Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Ability to consent in English
• Current symptomatic bacterial vaginosis infection
• History of at least 2 previous episodes of bacterial vaginosis in the past year

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University: lead
• Lupin Pharmaceuticals, Inc.: collaborator

Study Sites (1)

Indiana University Hospital - Coleman Center for Women

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Vaginosis, Bacterial

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Results Point of Contact

• Title: Chemen M. Neal, Associate Professor
• Organization: Indiana University School of Medicine

chmtate@iupui.edu

3172789639

Study Officials

• Chemen Neal, MD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: September 5, 2021
• Study Start: July 9, 2021
• Primary Completion: October 7, 2022
• Study Completion: October 7, 2022
• Last Updated: February 5, 2024
• Results First Posted: February 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)