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LACTIN-V Study for Recurrent Bacterial Vaginosis
NCT02766023 · View on ClinicalTrials.gov ↗
Study Summary
This Phase 2b trial is designed to provide a screening evaluation for the hypothesis that, following a 5-day treatment with MetroGel® to treat BV, L. crispatus CTV-05 (LACTIN-V, Osel, Inc.) administered at 2 x 10\^9 cfu/dose using a vaginal applicator reduces the 12-week incidence of BV recurrence when compared to placebo. The primary objectives of this study are: 1) To estimate the efficacy of repeated doses of LACTIN-V (2 x 10\^9 cfu/dose) as compared to placebo in preventing BV recurrence by 12 weeks following treatment of BV with MetroGel vaginal gel (MetroGel). 2) To assess the safety of LACTIN-V over 24 weeks by comparing the incidence of AEs between individuals randomized to LACTIN-V or placebo.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Metronidazole
- BIOLOGICAL Lactobacillus crispatus CTV-05
Study Locations (4)
California
- University of California, San Diego - Antiviral Research Center — San Diego
- San Francisco General Hospital - Infectious Diseases — San Francisco
Illinois
- Cook County Health and Hospitals System - Ruth M Rothstein CORE Center — Chicago
Missouri
- Washington University School of Medicine in St. Louis - Infectious Disease Clinical Research Unit — St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 228 participants |
| Start Date | 2016-06-03 |
| Est. Completion | 2019-02-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02766023
The ClinicalTrials.gov registry entry for NCT02766023 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 228 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 3 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: NCT02766023 reports 4 study locations spanning 3 distinct geographic areas — top geographies include California, Illinois, Missouri. 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 NCT02766023 about?
NCT02766023 is a clinical study titled "LACTIN-V Study for Recurrent Bacterial Vaginosis". This Phase 2b trial is designed to provide a screening evaluation for the hypothesis that, following a 5-day treatment with MetroGel® to treat BV, L. crispatus CTV-05 (LACTIN-V, Osel, Inc.) administered at 2 x 10\^9 cfu/dose using a vaginal applicator reduces the 12-week incidence of BV recurrence w...
What is the current status of trial NCT02766023?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 228 participants. The study started on 2016-06-03. Estimated completion is 2019-02-11.
What conditions does trial NCT02766023 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 NCT02766023?
The interventions under investigation include: Placebo (OTHER), Metronidazole (DRUG), Lactobacillus crispatus CTV-05 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02766023?
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 NCT02766023 being conducted?
This trial has 4 study locations across California, Illinois, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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