RECRUITING

Evaluation of the Performance and Acceptability of a Synthetic Polyisoprene Male Condom Compared to a Natural Rubber Latex Condom

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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

This study is a masked (investigators, research staff), two-way crossover, randomized to sequence of use study designed to evaluate the acceptability and functional performance (breakage, slippage) of a silicone lubricated polyisoprene condom and a silicone lubricated natural rubber latex condom.

Official Title

Evaluation of the Performance and Acceptability of a Synthetic Polyisoprene Male Condom Compared to a Natural Rubber Latex Condom (Phase II Slippage/Breakage Study)

Quick Facts

Study Start:2024-01-02

Study Completion:2025-02-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06595836

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 Criteria	Exclusion Criteria
1. Between the ages of 18 and 45 (inclusive) 2. Willing and able to give written or electronic informed consent 3. Willing to respond to questions concerning their reproductive and contraceptive history and use of condoms contained either on self-administered questionnaires or interviews 4. Be sexually active (defined as averaging one vaginal coital act per week) 5. Protected against pregnancy by oral contraceptives, an IUD, an implant, contraceptive injections, contraceptive patch, or sterilization (tubal ligation or vasectomy) 6. Willing to use the study products for ten acts of vaginal intercourse within six weeks of study entry 7. In a mutually monogamous relationship with their study partner for at least 3 months and be willing to remain mutually monogamous throughout study participation 8. Agree not to use any vaginal or sexual lubricant except the product supplied by the study 9. Agree not to wear any genital piercing jewelry while using the study condoms 10. Agree not to use sex toys or drugs intended to enhance or diminish sexual response when using study condoms 11. Agree to return any unopened condoms 12. Reachable by telephone 13. Has home internet access, a valid personal email for each partner, reachable by phone, ability to videoconference and use electronic consent technology 14. Male partner agrees to ejaculate during vaginal intercourse 15. Willing to provide photo identification-	1. Currently participating in another similar clinical study or employed by a condom manufacturer or Essential Access Health 2. Female partner self-reported as pregnant 3. Allergic to natural rubber latex or polyisoprene, or has a history of recurrent adverse events following use of latex or polyisoprene products 4. Unable to follow instructions or strictly adhere to the visit schedule 5. At significant (high) risk of sexually transmitted infections, including HIV infection, or having a medical history of recurrent, serious sexually transmitted infection (e.g. gonorrhea, syphilis, Chlamydia) 6. Currently using condoms for protection against a known sexually transmitted infection 7. Taking any internally applied medication or oral medication to treat a genital condition 8. Male partner has had difficulty achieving or maintaining an erection, or achieving ejaculation in the last month under typical circumstances/ conditions. 9. Any self-reported genital condition (e.g. itching, burning, irritation, etc.) which, in the opinion of the investigator, could affect use of the study condoms or the ability to interpret study data -

Inclusion Criteria

Exclusion Criteria

1. Between the ages of 18 and 45 (inclusive)
2. Willing and able to give written or electronic informed consent
3. Willing to respond to questions concerning their reproductive and contraceptive history and use of condoms contained either on self-administered questionnaires or interviews
4. Be sexually active (defined as averaging one vaginal coital act per week)
5. Protected against pregnancy by oral contraceptives, an IUD, an implant, contraceptive injections, contraceptive patch, or sterilization (tubal ligation or vasectomy)
6. Willing to use the study products for ten acts of vaginal intercourse within six weeks of study entry
7. In a mutually monogamous relationship with their study partner for at least 3 months and be willing to remain mutually monogamous throughout study participation
8. Agree not to use any vaginal or sexual lubricant except the product supplied by the study
9. Agree not to wear any genital piercing jewelry while using the study condoms
10. Agree not to use sex toys or drugs intended to enhance or diminish sexual response when using study condoms
11. Agree to return any unopened condoms
12. Reachable by telephone
13. Has home internet access, a valid personal email for each partner, reachable by phone, ability to videoconference and use electronic consent technology
14. Male partner agrees to ejaculate during vaginal intercourse
15. Willing to provide photo identification-

1. Currently participating in another similar clinical study or employed by a condom manufacturer or Essential Access Health
2. Female partner self-reported as pregnant
3. Allergic to natural rubber latex or polyisoprene, or has a history of recurrent adverse events following use of latex or polyisoprene products
4. Unable to follow instructions or strictly adhere to the visit schedule
5. At significant (high) risk of sexually transmitted infections, including HIV infection, or having a medical history of recurrent, serious sexually transmitted infection (e.g. gonorrhea, syphilis, Chlamydia)
6. Currently using condoms for protection against a known sexually transmitted infection
7. Taking any internally applied medication or oral medication to treat a genital condition
8. Male partner has had difficulty achieving or maintaining an erection, or achieving ejaculation in the last month under typical circumstances/ conditions.
9. Any self-reported genital condition (e.g. itching, burning, irritation, etc.) which, in the opinion of the investigator, could affect use of the study condoms or the ability to interpret study data -

Contacts and Locations

Study Locations (Sites)

Essential Access

Berkeley, California, 94710

United States

Essential Access

Los Angeles, California, 90010-2648

United States

Collaborators and Investigators

Sponsor: Thai Nippon Rubber Industry Public Company Limited

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 Date2024-01-02

Study Completion Date2025-02-28

Study Record Updates

Study Start Date2024-01-02

Study Completion Date2025-02-28

Terms related to this study

Additional Relevant MeSH Terms

Condom Use