Trials / Completed
CompletedNCT01437722
Dose-ranging Study of SPL7013 Gel for the Prevention of Bacterial Vaginosis (BV)
A Double-blind, Multicenter, Randomized, Placebo-controlled, Dose-ranging Study to Determine the Efficacy and Safety of SPL7013 Gel (VivaGel®) Administered Vaginally to Prevent the Recurrence of Bacterial Vaginosis
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 205 (actual)
- Sponsor
- Starpharma Pty Ltd · Industry
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Not accepted
Summary
The purpose in this clinical study is to determine the efficacy of SPL7013 Gel for the prevention of recurrence of bacterial vaginosis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 1% SPL7013 Gel | vaginal gel |
| DRUG | 3% SPL7013 Gel | vaginal gel |
| DRUG | placebo gel | vaginal gel |
Timeline
- Start date
- 2011-08-01
- Primary completion
- 2012-12-01
- First posted
- 2011-09-21
- Last updated
- 2013-11-20
Source: ClinicalTrials.gov record NCT01437722. Inclusion in this directory is not an endorsement.