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NCT02709005 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of 5% Monolaurin Vaginal Gel Administered Intravaginally for the Treatment of Bacterial Vaginosis
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 109
- Enrollment target
NCT02709005: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT02709005 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 109 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (18% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02709005, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 109 participants
- Enrollment target
Study Summary
This is a Phase II, Double-Blind, Randomized, Placebo-Controlled, Multi-center Trial enrolling 120 subjects with Bacterial Vaginosis who will be randomized at a ratio of 2:1 to receive active test article (5% Monolaurin Vaginal Gel) or placebo (vehicle). The primary objective is to assess the safety and tolerability of 5% Monolaurin Vaginal Gel compared to vehicle placebo gel (excipients only) and to assess the efficacy by clinical cure rate of 5% Monolaurin Vaginal Gel compared to vehicle placebo gel at Visit 2.
Primary Outcome
A clinical cure was defined by normal Amsel criteria, including: normal physiological vaginal discharge, whiff test negative for any amine "fishy" odor, saline wet mount less than 20% for clue cells, and vaginal pH is \<=4.5. All four criteria had to be normal with none of the clinical failure criteria met to be considered a clinical cure. A clinical failure was defined by at least one of the following: one or more abnormal Amsel criteria, early discontinuation of study therapy due to lack of tr
Interventions
- OTHER Placebo
- DRUG 5% Monolaurin Vaginal Gel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 109 participants |
| Start Date | 2016-04-14 |
| Est. Completion | 2017-12-11 |
| Phase | Phase 2 |
What the finished NCT02709005 record still lists
NCT02709005 is an interventional study that assigns participants to a tested intervention. The registered 109 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (18% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02709005 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02709005 about?
NCT02709005 is a clinical study titled "Safety and Efficacy of 5% Monolaurin Vaginal Gel Administered Intravaginally for the Treatment of Bacterial Vaginosis". This is a Phase II, Double-Blind, Randomized, Placebo-Controlled, Multi-center Trial enrolling 120 subjects with Bacterial Vaginosis who will be randomized at a ratio of 2:1 to receive active test article (5% Monolaurin Vaginal Gel) or placebo (vehicle). The primary objective is to assess the safety...
What is the current status of trial NCT02709005?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 109 participants. The study started on 2016-04-14. Estimated completion is 2017-12-11.
What interventions are being tested in trial NCT02709005?
The interventions under investigation include: Placebo (OTHER), 5% Monolaurin Vaginal Gel (DRUG).
Who is sponsoring clinical trial NCT02709005?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02709005's enrollment target sits among peer trials
109 640th of 2000 higher than 1,361 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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