Comparing synthetic nitrile male condoms to standard latex male condoms

A Functional Performance and Acceptability Evaluation of Synthetic Nitrile Male Condom Compared to a Standard Latex Male Condom

This study is testing whether synthetic nitrile male condoms work as well as standard latex male condoms for couples in South Africa and California.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 600 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Karex Industries Sdn. Bhd. (Industry-sponsored)
• Locations: 3 sites (Berkeley, California and 2 other locations)
• Trial ID: NCT06079060 on ClinicalTrials.gov

What this trial studies

This trial is a multi-site, randomized 2-period cross-over study that compares the performance of synthetic nitrile male condoms to standard latex male condoms. Couples will use both types of condoms in a randomized order, completing a Condom Use Report after each use. The study aims to assess the function, safety, and acceptability of both condom types through follow-up visits after each set of five uses. A total of 300 couples will be enrolled, with half from Durban, South Africa, and half from California, USA.

Who should consider this trial

Good fit: Ideal candidates are sexually active couples aged 18 to 45 who are in a monogamous relationship and willing to participate in the study procedures.

Not a fit: Patients who are not in a monogamous relationship or those who do not regularly engage in sexual activity may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the effectiveness and acceptability of synthetic nitrile condoms, potentially offering a safer alternative for preventing sexually transmitted diseases.

How similar studies have performed: While this specific comparison may be novel, previous studies have shown varying success in evaluating alternative condom materials for safety and effectiveness.

Eligibility criteria

Inclusion 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 3 months; and intend to continue to be an exclusive (monogamous) sexual relationship with their spouse or partner while participating in this research study;
4. Be sexually active (defined as having at least one vaginal coital act per week);
5. Willing to give informed consent;
6. Willing to complete the male condom coital use reports;
7. Willing to use the study condoms as directed;
8. Agree to use only the study lubricant provided;
9. Agree to only use the study condoms sequentially during time of participation
10. Willing to adhere to the follow-up schedule and all study procedures;
11. Willing to provide research study staff with an address, phone number or other locator information while participating in the study;
12. Willing to participate in the study for the duration of 10 condom uses (approximately 2-3 months);
13. Willing to provide photo identification and/or have fingerprint scan to exclude co-enrolment in other research projects;
14. Female partner using hormonal or other non-barrier contraception (e.g. OCs, injectable, implant, Intrauterine device (IUD), or have had a tubal sterilization) or male partner vasectomised;
15. Agree to return any unopened condoms;
16. Male partner willing to ejaculate during vaginal intercourse;
17. Male partner willing to hold on to the condom ring when withdrawing the erect penis after sexual intercourse;
18. Agree to not bring study condoms in contact with genital or oral piercing jewelry
19. EAH: Both partners have valid personal email and operable mobile phones;
20. Former participant in Karex02 Study: male partner measures at least 118 mm in girth of erect penis.
21. Agree that information provided in Karex02 study may be used and combined with the information in this study

Exclusion Criteria:

1. Female partner is pregnant or desires to become pregnant during the time of the research study;
2. Either partner is known to be HIV positive (based on self report \[EAH\] or documented HIV-negative test result within past two months;
3. Self-reported history of recurrent sexually transmitted infection (e.g. gonorrhea, syphilis, Chlamydia);
4. Male partner has known erectile or ejaculatory dysfunction;
5. Either partner has genital piercing jewelry, uses genital beading or uses sex toys, drugs, medications or non-study devices that can affect sexual performance;
6. Either partner has known sensitivities or allergies to latex, synthetic nitrile, vaginal/sexual lubricants or lubricants used on condoms;
7. Either partner reports symptoms of STI (EAH) or has observable evidence of STI as determined through syndromic diagnosis and vaginal/penile examination (MRU);
8. Either partner is currently participating in another condom study;
9. Either partner is a past or current employee of Essential Access Health, University of the Witwatersrand, or Karex;
10. Either partner is a sex worker.

Where this trial is running

Berkeley, California and 2 other locations

• Essential Access Health — Berkeley, California, United States (Recruiting)
• Essential Access Health — Los Angeles, California, United States (Recruiting)
• MRU (MatCH Research Unit) — Durban, South Africa (Recruiting)

Study contacts

• Principal investigator: Mags Beksinska, PhD — MRU (MatCH Research Unit)
• Study coordinator: Mags Beksinska, PhD

Conditions Sexually Transmitted Diseases; Synthetic Male Condom; Slippage-Breakage Study