Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Suppression Of Bacterial Vaginosis (BV) [SUBVert]
NCT03930745 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03930745
The ClinicalTrials.gov registry entry for NCT03930745 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 81 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03930745 reports 4 study locations spanning 4 distinct geographic areas — top geographies include Alabama, California, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03930745?
The interventions under investigation include: Placebo (OTHER), TOL-463 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03930745?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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