Status:
COMPLETED
Evaluation of Synthetic Nitrile Male Condom Compared to Standard Latex Male Condom
Lead Sponsor:
Karex Industries Sdn. Bhd.
Collaborating Sponsors:
Match Research
Essential Access Health
Conditions:
Sexually Transmitted Diseases
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief Summary
Thia is a multi-site, randomised 2-period cross-over trial comparing five uses of a 61 mm width synthetic nitrile male condom with five uses of a 61 mm width standard latex male condom.
Detailed Description
A sequential randomised 2-period cross-over trial comparing five uses of a 61 mm width synthetic nitrile male condom with five uses of a 61 mm width standard latex male condom. Each couple will be ask...
Eligibility Criteria
Inclusion
- 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 3 months; and intend to continue to be an exclusive (monogamous) sexual relationship with their spouse or partner while participating in this research study;
- Be sexually active (defined as having at least one vaginal coital act per week);
- Willing to give informed consent;
- Willing to complete the male condom coital use reports;
- Willing to use the study condoms as directed;
- Agree to use only the study lubricant provided;
- Agree to only use the study condoms sequentially during time of participation
- 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;
- Willing to participate in the study for the duration of 10 condom uses (approximately 2-3 months);
- Willing to provide photo identification and/or have fingerprint scan to exclude co-enrolment in other research projects;
- 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;
- Agree to return any unopened condoms;
- Male partner willing to ejaculate during vaginal intercourse;
- Male partner willing to hold on to the condom ring when withdrawing the erect penis after sexual intercourse;
- Agree to not bring study condoms in contact with genital or oral piercing jewelry
- EAH: Both partners have valid personal email and operable mobile phones;
- Former participant in Karex02 Study: male partner measures at least 118 mm in girth of erect penis.
- Agree that information provided in Karex02 study may be used and combined with the information in this study
Exclusion
- Female partner is pregnant or desires to become pregnant during the time of the research study;
- Either partner is known to be HIV positive (based on self report \[EAH\] or documented HIV-negative test result within past two months;
- Self-reported history of recurrent sexually transmitted infection (e.g. gonorrhea, syphilis, Chlamydia);
- Male partner has known erectile or ejaculatory dysfunction;
- Either partner has genital piercing jewelry, uses genital beading or uses sex toys, drugs, medications or non-study devices that can affect sexual performance;
- Either partner has known sensitivities or allergies to latex, synthetic nitrile, vaginal/sexual lubricants or lubricants used on condoms;
- Either partner reports symptoms of STI (EAH) or has observable evidence of STI as determined through syndromic diagnosis and vaginal/penile examination (MRU);
- Either partner is currently participating in another condom study;
- Either partner is a past or current employee of Essential Access Health, University of the Witwatersrand, or Karex;
- Either partner is a sex worker.
Key Trial Info
Start Date :
October 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 11 2024
Estimated Enrollment :
305 Patients enrolled
Trial Details
Trial ID
NCT06079060
Start Date
October 6 2023
End Date
October 11 2024
Last Update
October 24 2025
Active Locations (3)
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1
Essential Access Health
Berkeley, California, United States, 94710
2
Essential Access Health
Los Angeles, California, United States, 90010
3
MRU (MatCH Research Unit)
Durban, South Africa, 4000