Trials / Completed
CompletedNCT01201057
Dose Ranging Study of SPL7013 Gel for Treatment of Bacterial Vaginosis (BV)
A Double-blind, Multi-center, Randomized, Placebo Controlled, Dose-ranging Study to Determine the Efficacy and Safety of SPL7013 Gel (VivaGel®) Administered Vaginally in the Treatment of Bacterial Vaginosis
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 132 (actual)
- Sponsor
- Starpharma Pty Ltd · Industry
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine the efficacy of SPL7013 Gel in the treatment of bacterial vaginosis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 0.5% SPL7013 Gel | Vaginal gel |
| DRUG | 1.0% SPL7013 Gel | Vaginal gel |
| DRUG | 3.0% SPL7013 Gel | Vaginal gel |
| OTHER | Placebo Gel | Vaginal gel |
Timeline
- Start date
- 2010-08-01
- Primary completion
- 2011-03-01
- Completion
- 2011-05-01
- First posted
- 2010-09-14
- Last updated
- 2019-06-06
- Results posted
- 2019-06-06
Locations
5 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01201057. Inclusion in this directory is not an endorsement.