Safety, Tolerance and Acceptability Trial of the Invisible Condom® in Healthy Women
|ClinicalTrials.gov Identifier: NCT00136643|
Recruitment Status : Completed
First Posted : August 29, 2005
Last Update Posted : October 10, 2007
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections Sexually Transmitted Diseases||Drug: Invisible Condom®||Phase 1 Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||452 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||June 2005|
|Study Completion Date :||July 2007|
- Safety and tolerance outcomes: Subjective assessment; Objective assessment
- Acceptability assessment
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00136643
|Laboratoire de Santé Hygiène Mobile|
|Principal Investigator:||Michel G. Bergeron, MD, FRCPC||Prof. and Director of Infectious Diseases Research Center, Laval University|