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NCT00331032 · ClinicalTrials.gov registry record · Phase 1
VivaGel™ in Healthy Young Women
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
NCT00331032 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 56 participants.
The verdict
NCT00331032, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
Study Summary
The purpose of this study is to test the safety and tolerability of a medication applied vaginally twice daily in females versus placebo (inactive substance). Study participants will include 60 women, ages 18-24, non-pregnant, previously sexually active, Human Immunodeficiency Virus (HIV) negative and sexually transmitted infection (STI) free, in San Francisco or Kisuma, Kenya. Each study participant will be followed for 14 days of product use and an additional 7 days for safety assessments. Study procedures will include a physical exam with a pap smear, urine testing, blood sample testing, and a colposcopy (exam of the vagina and cervix using a lighted magnifying instrument). Information learned from this study may help to develop a safe and effective medication that could prevent herpes simplex virus and HIV. Participants may be involved in study related procedures for up to 55 days.
Interventions
- DRUG Placebo
- DRUG 3% w/w SPL7013 Gel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2006-12 |
| Est. Completion | 2007-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00331032
The ClinicalTrials.gov registry entry for NCT00331032 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00331032 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00331032 about?
NCT00331032 is a clinical study titled "VivaGel™ in Healthy Young Women". The purpose of this study is to test the safety and tolerability of a medication applied vaginally twice daily in females versus placebo (inactive substance). Study participants will include 60 women, ages 18-24, non-pregnant, previously sexually active, Human Immunodeficiency Virus (HIV) negative a...
What is the current status of trial NCT00331032?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2006-12. Estimated completion is 2007-11.
What interventions are being tested in trial NCT00331032?
The interventions under investigation include: Placebo (DRUG), 3% w/w SPL7013 Gel (DRUG).
Who is sponsoring clinical trial NCT00331032?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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