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NCT02766023 · ClinicalTrials.gov registry record · Phase 2
LACTIN-V Study for Recurrent Bacterial Vaginosis
A Phase 2 study of Bacterial Vaginosis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 228
- Enrollment target
- 4
- Study locations
NCT02766023: Completed Phase 2 study of Bacterial Vaginosis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT02766023 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 228 participants, below the 323-participant average among 15 other Bacterial Vaginosis trials with a reported enrollment target (29% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02766023, 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
- 228 participants
- Enrollment target
- 4
- Study locations
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.
Primary Outcome
Adverse events and serious adverse events were collected during the entire study period. Relatedness to study product was assessed by the site investigator according to the protocol definition of related as "There is a reasonable possibility that the study product caused the AE. Reasonable possibility means that there is evidence to suggest a causal relationship between the study product and the AE."
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 |
What the finished NCT02766023 record still lists
NCT02766023 is an interventional study that assigns participants to a tested intervention. The registered 228 participants enrollment target is mid-sized for trials with a published cap, below the 323-participant average among 15 other Bacterial Vaginosis trials with a reported enrollment target (29% lower).
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.
NCT02766023 reports a single indexed study location in California, Illinois, Missouri.
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.
What interventions are being tested in trial NCT02766023?
The interventions under investigation include: Placebo (OTHER), Metronidazole (DRUG), Lactobacillus crispatus CTV-05 (BIOLOGICAL).
Who is sponsoring clinical trial NCT02766023?
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 NCT02766023 being conducted?
This trial has 4 study locations across California, Illinois, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02766023's enrollment target sits among peer trials
228 9th of 15 higher than 7 of 15 other Bacterial Vaginosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bacterial Vaginosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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