Status:
COMPLETED
Synthetic Male Condom Slippage-Breakage Study
Lead Sponsor:
Church & Dwight Company, Inc.
Collaborating Sponsors:
Essential Access Health
Conditions:
Contraceptive
Sexually Transmitted Diseases
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief Summary
This is a multi-site, double-blind, crossover, randomized phase II study to evaluate the functional performance of a synthetic male condom as compared to a marketed latex condom.
Detailed Description
Approximately 300 heterosexual monogamous couples not at risk of pregnancy or transmission of sexually transmitted infections (STI) will be recruited to use both the test (synthetic) condom and a cont...
Eligibility Criteria
Inclusion
- Willing and able to give written or electronic informed consent
- Willing to respond to questions concerning participant's reproductive and contraceptive history and use of condoms contained either on self-administered surveys or interviews
- Agree to have vaginal intercourse at least once weekly
- Protected against pregnancy by oral contraceptives, an intrauterine device (IUD), an implant, contraceptive injections, contraceptive patch, or sterilization (tubal ligation or vasectomy)
- Willing to use the study products for eight acts of vaginal intercourse within four weeks of study entry
- In a mutually monogamous relationship with participant's study partner for at least 3 months prior to screening and be willing to remain mutually monogamous throughout study participation
- Agree not to use any vaginal or sexual lubricant except the product supplied by the study (AstroglideTM)
- Agree not to wear any genital piercing jewellery while using the study condoms
- Agree not to use sex toys or drugs intended to enhance or diminish sexual response when using study condoms
- Agree to return any unopened condoms
- Reachable by telephone
- Has home internet access, a valid personal email for each partner, ability to videoconference and use electronic signature technology
- Male partner agrees to ejaculate during vaginal intercourse
Exclusion
- Currently participating in another similar clinical study or employed by a condom manufacturer or Essential Access Health
- Female partner self-reported as pregnant
- Allergic to natural rubber latex or styrene-isoprene-styrene (SIS), or has a history of recurrent adverse events following use of latex or SIS products
- Unable to follow instructions or strictly adhere to the visit schedule
- At significant (high) risk of sexually transmitted infections, including human immunodeficiency virus (HIV) infection or having a medical history of recurrent, serious sexually transmitted infection (e.g., gonorrhea, syphilis, Chlamydia)
- Currently using condoms for protection against a known sexually transmitted infection
- Taking any externally applied medication or oral medication to treat a genital condition
- Male partner has had difficulty achieving or maintaining an erection or achieving ejaculation in the last month prior to screening under typical circumstances/ conditions.
- Any self-reported genital condition (e.g., itching, burning, irritation, etc.) which, in the opinion of the investigator, could affect the use of the study condoms or the ability to interpret study data
Key Trial Info
Start Date :
June 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 12 2023
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT05370196
Start Date
June 10 2022
End Date
May 12 2023
Last Update
November 8 2023
Active Locations (2)
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1
Essential Access Health
Berkeley, California, United States, 94710
2
Essential Access Health
Los Angeles, California, United States, 90010