Status:
COMPLETED
Assessing Preference for 3 Female Condoms: A Comparative Evaluation of the PATH Woman's Condom, FC2 and the Reddy 6
Lead Sponsor:
FHI 360
Collaborating Sponsors:
United States Agency for International Development (USAID)
University of Witwatersrand, South Africa
Conditions:
Contraception
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Evaluation of preference for three female condoms (FC).
Detailed Description
The primary goal of this study was to identify the female condom most preferred by study participants. This provided USAID with data to make informed decisions regarding female condom purchases. The s...
Eligibility Criteria
Inclusion
- All women enrolled in this research must meet the following selection criteria:
- must be at least 18 years of age.
- must be literate (able to read a newspaper or letter easily).
- must be sexually active (defined as having at least two vaginal coital acts per week and not being abstinent in the month prior to enrollment).
- must be in an exclusive (monogamous) sexual relationship with her spouse or partner while participating in this research study.
- must have been in a sexual relationship with this partner for at least 6 months.
- must be without evidence of STI as determined through syndromic diagnosis and vaginal examination.
- must be on hormonal or other non-barrier contraception (e.g. OCs, injectables, IUD, or have had a tubal sterilization or be post-menopausal-defined as 12 months with no period).
- must be willing to give informed consent.
- must be able to complete condom use log.
- must be willing to use the study condoms as directed.
- must be willing to adhere to the follow-up schedule and all study procedures.
- must have successfully completed a given phase of study before advancing into subsequent phases (e.g. successfully completing Part 1 before advancing to Part 2, etc.).
- must be willing to provide research study staff with an address, phone number or other locator information while participating in the study.
- must be willing to participate in the study for up to six months.
Exclusion
- must not be a sex worker.
- must not be pregnant (as determined by pregnancy testing) or planning a pregnancy during the time of the research study.
- must not be breastfeeding.
- must not have known sensitivities or allergies to latex, polyurethane, vaginal/sexual lubricants or the lubricants used on condoms.
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT01452503
Start Date
May 1 2007
End Date
April 1 2008
Last Update
September 13 2023
Active Locations (1)
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1
Commercial City Clinic Department of Health
Durban, South Africa, 4001