Status:
COMPLETED
Safety, Tolerance and Acceptability Trial of the Invisible Condom® in Healthy Women
Lead Sponsor:
Laval University
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Centre Hospitalier de l'Universite Laval (CHUL)
Conditions:
HIV Infections
Sexually Transmitted Diseases
Eligibility:
FEMALE
18-49 years
Phase:
PHASE1
PHASE2
Brief 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 formulati...
Detailed 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 ...
Eligibility Criteria
Inclusion
- Sign an informed consent
- Healthy female subjects aged between 18 to 49. Healthy female subjects are defined as individuals who are free from clinically significant illness or disease as determined by their medical history, physical examination and laboratory tests.
- Normal physical and gynecological examinations
- Normal colposcopic examination
- Have regular menstrual cycle with 21-40 days between menses
- HIV-negative subjects and at low risk of acquiring HIV
- At low risk of getting STIs (i.e. sexually abstinent or having history of protected sexual intercourse or having a stable sexual partner). Sexual intercourse is defined here as vaginal penetration. Stable sexual partner is defined as the same sexual partner for the length of the study.
- Agreeing to abstain from sexual intercourse from screening to the end of the study (for sexually abstinent subjects).
- Agreeing to have sexual intercourse a minimum of 4 times for each period of two weeks of gel application (for sexually active subjects)
Exclusion
- Clinically significant abnormal physical and/or gynecological examination
- Clinically significant abnormal laboratory findings
- Allergy to applicator material (polyethylene) or to gel polymer (polyoxyethylene-polyoxypropylene) or to latex
- Participation in any investigational study involving drugs, vaccines or microbicides in the last 30 days
- History of toxic shock syndrome
- HIV infection
- Bacterial vaginosis or Candida or Trichomonas vaginitis at time of screening
- STIs (gonorrhea, chlamydia, syphilis, genital herpes, chancroid) at time of screening
- Breakthrough menstrual bleeding, or vaginal bleeding during or following sexual intercourse, in the last 3 months
- Intravenous (IV) drug use except for medical reasons in the last year
- Pregnant at enrolment or breast-feeding
- Having received antibiotics in the last 14 days
- Subjects considered as unreliable or unable to understand or follow the study protocol directions
- Use of an intrauterine device
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
End Date :
July 1 2007
Estimated Enrollment :
452 Patients enrolled
Trial Details
Trial ID
NCT00136643
Start Date
June 1 2005
End Date
July 1 2007
Last Update
October 10 2007
Active Locations (1)
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1
Laboratoire de Santé Hygiène Mobile
Yaoundé, Cameroon