Status:
COMPLETED
Functional Performance and Acceptability Study of Synthetic Nitrile, and Latex Graphene, Compared to Standard Latex Male Condom
Lead Sponsor:
Prof Mags Beksinska
Conditions:
Functional Performance
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief Summary
Two new male condoms have been developed - one made of synthetic nitrile and the other made of latex graphene. Both new condoms are of the same design as a standard latex male condom. The aim of this ...
Detailed Description
Two new male condoms have been developed - one made of synthetic nitrile and the other made of latex graphene. Both new condoms are of the same design as a standard latex male condom. Purpose: The ai...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- All couples enrolled in this research must meet the following selection criteria:
- Be between the ages of 18 and 45 years (inclusive);
- Be literate (able to read a newspaper or letter easily);
- Have been in an exclusive (monogamous) sexual relationship with partner for at least 6 months; and intend to continue to be an exclusive (monogamous) sexual relationship with partner with their spouse or partner while participating in this research study;
- Not planning a pregnancy during the time of the research study;
- Be sexually active (defined as having at least two vaginal coital acts per week and not being abstinent in the month prior to enrolment);
- Not have any genital piercings, use genital beading or any other drugs or non-study devices that can affect sexual performance;
- Not have known sensitivities or allergies to latex, polyurethane, vaginal/sexual lubricants or the lubricants used on condoms;
- Be without observable evidence of Sexually transmitted infections (STI) as determined through syndromic diagnosis and vaginal/penile examination;
- Not be HIV positive
- Willing to give informed consent;
- Willing to complete the male condom 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 15 condom uses (approximately 3- 5 months.
- Willing to have fingerprint scan to check for co-enrolment in other research projects Female partner only: -
- Using hormonal or other non-barrier contraception (e.g. Oral Contraceptives (OC), injectable, implant, Intra Uterine Device (IUD), or have had a tubal sterilization);
- Must not be pregnant (as determined by pregnancy testing)
- Not be menopausal (defined as 12 months without menstruation);
- Not have had a hysterectomy; Male partner only: -
- Not have known erectile or ejaculatory dysfunction.
Exclusion
Key Trial Info
Start Date :
May 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 18 2022
Estimated Enrollment :
480 Patients enrolled
Trial Details
Trial ID
NCT04881877
Start Date
May 11 2021
End Date
February 18 2022
Last Update
March 2 2022
Active Locations (1)
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1
MatCH Research Unit [Maternal, Adolescent and Child Health Research Unit]
Durban, KwaZulu-Natal, South Africa, 4001