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

NCT00136643 | Completed Phase 1

• 2 other identifiers: CRI-INV.06FRN: 67531
• Study Type: interventional
• Target: 452
• Locations: 1 country
• Sites: 1

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 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

Keywords

microbicide; Women; Prevention; HIV; STIs; HIV Seronegativity; prevention of sexually transmitted infections including HIV.

Outcome Measures

Primary Outcomes (1)

• Safety and tolerance outcomes: Subjective assessment; Objective assessment

Secondary Outcomes (1)

• Acceptability assessment

Interventions

Invisible Condom® DRUG

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Laval University: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Centre Hospitalier de l'Universite Laval (CHUL): collaborator

Study Sites (1)

Laboratoire de Santé Hygiène Mobile

Yaoundé, Cameroon

Location

MeSH Terms

Conditions

HIV Infections; Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michel G. Bergeron, MD, FRCPC

  Prof. and Director of Infectious Diseases Research Center, Laval University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 26, 2005
• First Posted: August 29, 2005
• Study Start: June 1, 2005
• Study Completion: July 1, 2007
• Last Updated: October 10, 2007

Record last verified: 2007-10

Locations

CA (1)