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

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Sexually Transmitted DiseasesSynthetic Male CondomSlippage-Breakage Study

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-10-06
Study Completion:2024-10-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06079060

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Be between the ages of 18 and 45 years (inclusive);
  2. 2. Be literate (able to read a newspaper or letter easily);
  3. 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. 4. Be sexually active (defined as having at least one vaginal coital act per week);
  5. 5. Willing to give informed consent;
  6. 6. Willing to complete the male condom coital use reports;
  7. 7. Willing to use the study condoms as directed;
  8. 8. Agree to use only the study lubricant provided;
  9. 9. Agree to only use the study condoms sequentially during time of participation
  10. 10. Willing to adhere to the follow-up schedule and all study procedures;
  11. 11. Willing to provide research study staff with an address, phone number or other locator information while participating in the study;
  12. 12. Willing to participate in the study for the duration of 10 condom uses (approximately 2-3 months);
  13. 13. Willing to provide photo identification and/or have fingerprint scan to exclude co-enrolment in other research projects;
  14. 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. 15. Agree to return any unopened condoms;
  16. 16. Male partner willing to ejaculate during vaginal intercourse;
  17. 17. Male partner willing to hold on to the condom ring when withdrawing the erect penis after sexual intercourse;
  18. 18. Agree to not bring study condoms in contact with genital or oral piercing jewelry
  19. 19. EAH: Both partners have valid personal email and operable mobile phones;
  20. 20. Former participant in Karex02 Study: male partner measures at least 118 mm in girth of erect penis.
  21. 21. Agree that information provided in Karex02 study may be used and combined with the information in this study
  1. 1. Female partner is pregnant or desires to become pregnant during the time of the research study;
  2. 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. 3. Self-reported history of recurrent sexually transmitted infection (e.g. gonorrhea, syphilis, Chlamydia);
  4. 4. Male partner has known erectile or ejaculatory dysfunction;
  5. 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. 6. Either partner has known sensitivities or allergies to latex, synthetic nitrile, vaginal/sexual lubricants or lubricants used on condoms;
  7. 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. 8. Either partner is currently participating in another condom study;
  9. 9. Either partner is a past or current employee of Essential Access Health, University of the Witwatersrand, or Karex;
  10. 10. Either partner is a sex worker.

Contacts and Locations

Principal Investigator

Mags Beksinska, PhD
PRINCIPAL_INVESTIGATOR
MRU (MatCH Research Unit)

Study Locations (Sites)

Essential Access Health
Berkeley, California, 94710
United States
Essential Access Health
Los Angeles, California, 90010
United States

Collaborators and Investigators

Sponsor: Karex Industries Sdn. Bhd.

  • Mags Beksinska, PhD, PRINCIPAL_INVESTIGATOR, MRU (MatCH Research Unit)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-06
Study Completion Date2024-10-11

Study Record Updates

Study Start Date2023-10-06
Study Completion Date2024-10-11

Terms related to this study

Keywords Provided by Researchers

  • Synthetic Male Condom
  • Slippage-Breakage Study

Additional Relevant MeSH Terms

  • Sexually Transmitted Diseases