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Safety and Tolerability of the Vaginal Gel PRO 2000/5

NCT00006207 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2008-07-30

No results posted yet for this study

Summary

The purpose of this study is to determine whether the vaginal gel PRO 2000/5 causes irritation when used daily.

Studies have shown PRO 2000/5 is safe and well tolerated as a vaginal gel in healthy women who are not sexually active. However, it was not determined what side effects to skin in the vaginal area there might be in sexually active women.

Conditions

  • HIV Infections

Interventions

DRUG

PRO 2000

Sponsors & Collaborators

  • Procept

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Ken Mayer

  • Salim Abdool Karim

Study Design

Purpose
PREVENTION

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00006207 on ClinicalTrials.gov