Evaluation of 2 Synthetic Nitrile Male Condoms Compared to a Standard Latex Male Condom

Completed · Not applicable

Conditions studied: Sexually Transmitted Diseases

In brief

This is a multi-site, randomised 3-period cross-over trial evaluating the functional performance of two synthetic nitrile male condoms against a control latex male condom.

Key facts

Study ID

NCT05912283

Run by

Karex Industries Sdn. Bhd.

People needed

600

Starts

2023-06-02

Expected to finish

2024-01-31

Last updated by the study team

2024-05-28

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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 15 condom uses (approximately 3-5 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, 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;

You may not qualify if…

• 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 [MRU]);
• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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