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Sponsors and Collaborators: |
Laval University Canadian Institutes of Health Research (CIHR) Centre Hospitalier de l'Universite Laval (CHUL) |
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Information provided by: | Laval University |
ClinicalTrials.gov Identifier: | NCT00136643 |
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.
Condition | Intervention | Phase |
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HIV Infections Sexually Transmitted Diseases |
Drug: Invisible Condom® |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study |
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 |
Estimated Enrollment: | 452 |
Study Start Date: | June 2005 |
Study Completion Date: | July 2007 |
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.
Ages Eligible for Study: | 18 Years to 49 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Cameroon | |
Laboratoire de Santé Hygiène Mobile | |
Yaoundé, Cameroon |
Principal Investigator: | Michel G. Bergeron, MD, FRCPC | Prof. and Director of Infectious Diseases Research Center, Laval University |
Study ID Numbers: | CRI-INV.06, FRN: 67531 |
Study First Received: | August 26, 2005 |
Last Updated: | October 9, 2007 |
ClinicalTrials.gov Identifier: | NCT00136643 |
Health Authority: | Canada: Health Canada; United States: Food and Drug Administration; Cameroon: Ministry of Public Health |
microbicide Women Prevention HIV |
STIs HIV Seronegativity prevention of sexually transmitted infections including HIV. |
Genital Diseases, Female Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Acquired Immunodeficiency Syndrome |
Sexually Transmitted Diseases Healthy Genital Diseases, Male Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |