Status:
COMPLETED
A Functional Performance Study of The Wondaleaf Female Condom
Lead Sponsor:
Prof Mags Beksinska
Conditions:
HIV Prevention
Pregnancy Prevention
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
This research study will determine how well two female condoms perform when used during sex. One of these condoms (FC2) is already commercially available in South Africa. The other female condom, "Won...
Detailed Description
This research study will determine how well two female condoms perform when used during sex. One of these condoms (FC2) is already commercially available in South Africa. The other female condom, "Won...
Eligibility Criteria
Inclusion
- Be between the ages of 18 and 45 years (inclusive);
- Be literate (able to read a newspaper or letter easily);
- Be sexually active (defined as having at least two vaginal coital acts per week and not being abstinent in the month prior to enrolment);
- Be in an exclusive (monogamous) sexual relationship with her spouse or partner while participating in this research study;
- Have been in a sexual relationship with this partner for at least 6 months;
- Not be a sex worker;
- Not be pregnant (as determined by pregnancy testing) or planning a pregnancy during the time of the research study;
- Be without observable evidence of Sexually Transmitted Infections (STI) as determined through syndromic diagnosis and vaginal examination;
- Be using hormonal or other non-barrier contraception (e.g. Oral Contraception (OCs), injectable, implant, Intra Uterine Device (IUD), or have had a tubal sterilization);
- Not be menopausal (defined as 12 months without menstruation);
- Not have had a hysterectomy;
- Not have known sensitivities or allergies to latex, polyurethane, vaginal/sexual lubricants or the lubricants used on condoms;
- Willing to give informed consent;
- Willing to complete the FC coital use logs;
- Willing to use the study condoms as directed;
- Willing to adhere to the follow-up schedule and all study procedures;
- Willing to provide research study staff with an address, phone number or other locator information while participating in the study; and,
- Willing to participate in the study for the duration of 10 condom uses (approximately 2-4 months.
- Willing to have fingerprint scan to check for co-enrolment in other research projects
Exclusion
- None specified
Key Trial Info
Start Date :
March 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 18 2019
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT04076774
Start Date
March 27 2019
End Date
October 18 2019
Last Update
October 23 2019
Active Locations (1)
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1
MatCH Research Unit [Maternal, Adolescent and Child Health Research Unit]
Durban, KwaZulu-Natal, South Africa, 4001