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Safety Study of UC-781 Vaginal Microbicide

NCT00446979 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2013-04-19

No results posted yet for this study

Summary

This study will help determine whether UC-781 gel is safe when applied to the vagina twice daily for 14 days, and will assess whether women and men find the gel acceptable to use.

Conditions

  • HIV Infections

Interventions

DRUG

Placebo gel

HEC (hydroxyethyl cellulose) Control Gel applied vaginally twice daily for two weeks

DRUG

UC 781

UC 781 0.1% or UC 781 0.25%, applied vaginally twice daily for two intermenstrual weeks

Sponsors & Collaborators

Principal Investigators

  • Sara J Whitehead, MD, MPH · Centers for Disease Control and Prevention

  • Chitlada Utaipiboon, MD · Thailand MOPH - U.S. CDC Collaboration

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-06-30
Completion
2007-10-31

Countries

  • Thailand

Study Locations

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Entities

Companies

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 NCT00446979 on ClinicalTrials.gov