Safety and Acceptability of SPL7013 Gel (VivaGel™) in Sexually Active Women
Public ClinicalTrials.gov record NCT00442910. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase 1 Study of the Safety and Acceptability of 3% w/w SPL7013 Gel (VivaGel™) Applied Vaginally in Sexually Active Young Women
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
There is an urgent need for HIV prevention methods that women can initiate and control themselves. Topical microbicides, substances that kill microbes, represent one such method. The purpose of this study is to assess the safety and to evaluate the acceptability of 3% w/w SPL7013 gel, a topical microbicide, when administered intravaginally for 14 consecutive days in healthy, sexually active HIV uninfected women.
Study identification
- NCT ID
- NCT00442910
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 61 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 24 Years
- Sex
- Female
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 30, 2007
- Primary completion
- Nov 30, 2009
- Completion
- Nov 30, 2009
- Last update posted
- Jun 23, 2010
2007 – 2009
United States locations
- U.S. sites
- 2
- U.S. states
- 2
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of South Florida | Tampa | Florida | 33606 | — |
| Center for Family Planning Research, Magee-Womens Hospital | Pittsburgh | Pennsylvania | 15213-3180 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00442910, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 23, 2010 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00442910 live on ClinicalTrials.gov.