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Completed Phase 1 Interventional Accepts healthy volunteers

Safety and Acceptability of SPL7013 Gel (VivaGel™) in Sexually Active Women

ClinicalTrials.gov ID: NCT00442910

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.

ClinicalTrials.gov public records Last synced Sep 3, 2026, 4:22 AM EDT

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
Lead sponsor
Starpharma Pty Ltd
Industry
Enrollment
61 participants

Conditions and interventions

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.

View official ClinicalTrials.gov record →