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NCT03930745 · ClinicalTrials.gov registry record · Phase 2
Suppression Of Bacterial Vaginosis (BV) [SUBVert]
A Phase 2 study of Bacterial Vaginosis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 81
- Enrollment target
- 4
- Study locations
NCT03930745: Completed Phase 2 study of Bacterial Vaginosis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT03930745 is a Phase 2 study of Bacterial Vaginosis that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 81 participants, below the 333-participant average among 15 other Bacterial Vaginosis trials with a reported enrollment target (76% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03930745, a Phase 2 study of Bacterial Vaginosis, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 81 participants
- Enrollment target
- 4
- Study locations
Study Summary
A Phase II randomized, double-blind, placebo-controlled study screening approximately 600 adult females, aged 18-55, with a goal to enroll approximately 250 participants to achieve 200 evaluable participants at the test of cure (TOC) visit. The study is designed to determine the clinical efficacy of an investigational product (IP), TOL-463 Insert, in suppressing Recurrent Bacterial Vaginosis (RBV) when administered to women who have a history of RBV and have been successfully cleared of their current Bacterial Vaginosis (BV) infection administering 500 mg of oral metronidazole, twice a day for 7 days or another CDC-recommended BV treatment. Patient participation will be approximately 100 days while the study is conducted at 4 sites within the United States. The primary objective of the study is to evaluate the clinical efficacy of a twice-weekly application of TOL-463 vaginal insert in suppression of BV in women with a history of RBV following successful induction with oral metronidazole or a CDC-recommended BV treatment.
Primary Outcome
Recurrent bacterial vaginosis (RBV) was defined as the presence of at least three out of the following four Amsel criteria: positive KOH whiff test, homogeneous discharge characteristic of BV, clue cells comprising at least 20% of vaginal squamous epithelial cells, and vaginal pH \> 4.5. Participants who had post-baseline efficacy results but were lost to follow-up before study completion were considered "treatment failures" and counted toward the number of participants with recurrence of BV.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG TOL-463
Study Locations (4)
Alabama
- University of Alabama at Birmingham School of Medicine - Infectious Disease - Birmingham
California
- University of California, San Diego - Antiviral Research Center - La Jolla
Illinois
- Cook County Health and Hospitals System - Ruth M Rothstein CORE Center - Chicago
Pennsylvania
- Magee Women's Hospital of UPMC - Reproductive Infectious Disease Research - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2019-09-09 |
| Est. Completion | 2021-12-06 |
| Phase | Phase 2 |
What the finished NCT03930745 record still lists
NCT03930745 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, below the 333-participant average among 15 other Bacterial Vaginosis trials with a reported enrollment target (76% lower).
The record links to 1 condition, with Bacterial Vaginosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03930745 reports a single indexed study location in Alabama, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT03930745 about?
NCT03930745 is a clinical study titled "Suppression Of Bacterial Vaginosis (BV) [SUBVert]". A Phase II randomized, double-blind, placebo-controlled study screening approximately 600 adult females, aged 18-55, with a goal to enroll approximately 250 participants to achieve 200 evaluable participants at the test of cure (TOC) visit. The study is designed to determine the clinical efficacy of...
What is the current status of trial NCT03930745?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 81 participants. The study started on 2019-09-09. Estimated completion is 2021-12-06.
What conditions does trial NCT03930745 study?
This clinical trial studies the following conditions: Bacterial Vaginosis.
What interventions are being tested in trial NCT03930745?
The interventions under investigation include: Placebo (OTHER), TOL-463 (DRUG).
Who is sponsoring clinical trial NCT03930745?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03930745 being conducted?
This trial has 4 study locations across Alabama, California, Illinois, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03930745's enrollment target sits among peer trials
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