Clinical trial
Safety and Acceptability of SPL7013 Gel (VivaGel™) in Sexually Active Women
NCT00442910 · Starpharma Pty Ltd, Industry · Completed
Key facts
| NCT number | NCT00442910 |
|---|---|
| Title | Safety and Acceptability of SPL7013 Gel (VivaGel™) in Sexually Active Women |
| Official title | Phase 1 Study of the Safety and Acceptability of 3% w/w SPL7013 Gel (VivaGel™) Applied Vaginally in Sexually Active Young Women |
| Lead sponsor | Starpharma Pty Ltd, Industry |
| Collaborators | National Institute of Allergy and Infectious Diseases (NIAID) NIH Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Microbicide Trials Network |
| Status | Completed |
| Phase | Phase 1 |
| Study type | Interventional |
| Conditions | Healthy |
| Intervention type | Drug |
| Interventions | 3% SPL7013 Gel (VivaGel), Placebo Gel, HEC Placebo Gel |
| Enrollment | 61 |
| Start date | Jul 1, 2007 |
| Primary completion | Dec 1, 2009 |
| Completion | Dec 1, 2009 |
| First posted | Mar 5, 2007 |
| Last update posted | Jun 24, 2010 |
| Countries | Puerto Rico, United States |
At a glance
- 1–9 Study sites
- No Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: