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

HIV Infections Clinical Trial

Official title: A Phase I/II Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerance and Acceptability of a Vaginal Gel Containing Sodium Lauryl Sulfate (Invisible Condom®) in Healthy Female Subjects

Status Completed

Clinical Trial 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.

Clinical Trial Description

Objectives: The objectives of this Phase I/II clinical trial are to evaluate the safety, tolerance and acceptability of a gel formulation containing sodium lauryl sulfate (SLS) (compared to gel alone and placebo) when applied intravaginally in healthy volunteers.

Design: In part A of the protocol, three groups: gel alone, gel plus SLS, and placebo will be tested for safety, tolerance and acceptability when applied intravaginally once, twice or three times daily for 14 days in 252 healthy subjects. The volunteers will be divided as follow: 36 sexually abstinent healthy subjects (12 per group) will apply the gel, gel plus SLS or the placebo once daily for 14 days; 72 sexually active healthy subjects (24 per group) will apply the gel, gel plus SLS or the placebo once daily for 14 days; 72 sexually active healthy subjects (24 per group) will apply the gel, gel plus SLS or the placebo twice daily for 14 days and 72 sexually active healthy subjects (24 per group) will apply the gel, gel plus SLS or the placebo three times daily for 14 days. The gel will be applied between menses. For the sexually active group, the gel should be applied less than 1 hour before sexual intercourse, if planned. Subjects will have vaginal intercourse a minimum of 4 times in a 2-week period of gel application.

In part B of the protocol, the extended safety of the gel alone, gel plus SLS and placebo will be studied when applied intravaginally twice daily for 8 weeks in sexually active healthy subjects. In this part B (actually represents Phase II of the trial), 80 healthy sexually active subjects for the gel alone group and 80 subjects for the gel + SLS group and 40 subjects for the placebo group, will be studied. The part B involves the participation of a total of 200 subjects. Subjects will have vaginal intercourse a minimum of 4 times in a 2-week period of gel application. The gel will be applied between menses. The gel should be applied less than 1 hour before sexual intercourse, if planned, but no more than twice a day. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections
• Sexually Transmitted Diseases

• NCT number: NCT00136643
• Study type: Interventional
• Source: Laval University
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: June 2005
• Completion date: July 2007