Functional Performance and Acceptability Study of Synthetic Nitrile, and Latex Graphene, Compared to Standard Latex Male Condom

Launched by PROF MAGS BEKSINSKA · May 5, 2021

Keywords

ClinConnect 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.

Purpose: The aim of the study is to evaluate the functional performance of two new male condoms compared to a control latex male condom.

Study design: The study is a randomized three-period cross-over trial of two new male condoms and a control latex male condom. The study will enrol 240 couples, anticipating that at least 200 couples will complete the study. Each couple will be asked to use five latex graph...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• All couples enrolled in this research must meet the following selection criteria:
• • 1. Be between the ages of 18 and 45 years (inclusive);
• • 2. Be literate (able to read a newspaper or letter easily);
• • 3. 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;
• • 4. Not planning a pregnancy during the time of the research study;
• • 5. Be sexually active (defined as having at least two vaginal coital acts per week and not being abstinent in the month prior to enrolment);
• • 6. Not have any genital piercings, use genital beading or any other drugs or non-study devices that can affect sexual performance;
• • 7. Not have known sensitivities or allergies to latex, polyurethane, vaginal/sexual lubricants or the lubricants used on condoms;
• • 8. Be without observable evidence of Sexually transmitted infections (STI) as determined through syndromic diagnosis and vaginal/penile examination;
• • 9. Not be HIV positive
• • 10. Willing to give informed consent;
• • 11. Willing to complete the male condom coital use logs;
• • 12. Willing to use the study condoms as directed;
• • 13. Willing to adhere to the follow-up schedule and all study procedures;
• • 14. Willing to provide research study staff with an address, phone number or other locator information while participating in the study; and,
• • 15. Willing to participate in the study for the duration of 15 condom uses (approximately 3- 5 months.
• • 16. Willing to have fingerprint scan to check for co-enrolment in other research projects Female partner only: -
• • 17. Using hormonal or other non-barrier contraception (e.g. Oral Contraceptives (OC), injectable, implant, Intra Uterine Device (IUD), or have had a tubal sterilization);
• • 18. Must not be pregnant (as determined by pregnancy testing)
• • 19. Not be menopausal (defined as 12 months without menstruation);
• • 20. Not have had a hysterectomy; Male partner only: -
• • 21. Not have known erectile or ejaculatory dysfunction.