Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02709005
The ClinicalTrials.gov registry entry for NCT02709005 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 109 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 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02709005 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.