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Safety, Tolerance and Acceptability Trial of the Invisible Condom® in Healthy Women

NCT00136643 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 452

Last updated 2007-10-10

No results posted yet for this study

Summary

The objectives of this clinical study are to evaluate the extended safety, tolerance and acceptability of a vaginal gel formulation when applied in 452 healthy women volunteers. This vaginal formulation was shown to be well tolerated in a previous smaller clinical study. The formulation is being developed as a microbicide for the prevention of sexually transmitted infections (STIs) including HIV.

Conditions

  • HIV Infections
  • Sexually Transmitted Diseases

Interventions

DRUG

Invisible Condom®

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Centre Hospitalier de l'Universite Laval (CHUL)

    collaborator UNKNOWN

  • Laval University

    lead OTHER

Principal Investigators

  • Michel G. Bergeron, MD, FRCPC · Prof. and Director of Infectious Diseases Research Center, Laval University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2005-06-30
Completion
2007-07-31

Countries

  • Cameroon

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 NCT00136643 on ClinicalTrials.gov