Trials / Completed
CompletedNCT00740584
Retention and Duration of Activity of SPL7013 (VivaGel®) After Vaginal Dosing.
Assessment of Local Retention and Duration of Activity of SPL7013 Following Vaginal Application of 3% SPL7013 Gel (VivaGel) in Healthy Volunteers
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Starpharma Pty Ltd · Industry
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
To assess the retention and anti-viral activity (human immunodeficiency virus (HIV) and herpes simplex virus 2 (genital herpes, HSV-2) of SPL7013 in cervicovaginal samples taken up to 24 hours after administration of 3% SPL7013 in the vagina. There is no hypothesis for this study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 3% SPL7013 Gel (VivaGel) | A single application of VivaGel applied to the vagina on five separate occasions, each occasion separated by a minimum of 5 days. |
Timeline
- Start date
- 2008-08-01
- Primary completion
- 2009-03-01
- Completion
- 2009-03-01
- First posted
- 2008-08-25
- Last updated
- 2018-10-30
- Results posted
- 2012-08-14
Locations
1 site across 1 country: Australia
Source: ClinicalTrials.gov record NCT00740584. Inclusion in this directory is not an endorsement.