CompletedNot Applicable

Evaluation of Synthetic Nitrile Male Condom Compared to Standard Latex Male Condom

United States, South Africa305 participantsStarted 2023-10-06

Plain-language 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.

Who can participate

Age range18 Years – 45 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion 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 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;

Exclusion criteria

✕. 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;

What they're measuring

Clinical breakage

Timeframe: 3 - 5 months

Clinical slippage

Timeframe: 3 - 5 months

Clinical failure

Timeframe: 3 - 5 months

Trial details

NCT IDNCT06079060

SponsorKarex Industries Sdn. Bhd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-09-30

View on ClinicalTrials.gov More Sexually Transmitted Diseases trials

Who can participate

Age range18 Years – 45 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion 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 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;

Exclusion criteria

✕. 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;