Actively Recruiting
Evaluation of the Performance and Acceptability of a Synthetic Polyisoprene Male Condom Compared to a Natural Rubber Latex Condom
Led by Thai Nippon Rubber Industry Public Company Limited · Updated on 2024-09-19
300
Participants Needed
2
Research Sites
60 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of the Performance and Acceptability of a Synthetic Polyisoprene Male Condom Compared to a Natural Rubber Latex Condom
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between the ages of 18 and 45 (inclusive)
- Willing and able to give written or electronic informed consent
- Willing to respond to questions about reproductive and contraceptive history and condom use
- Sexually active, averaging one vaginal intercourse act per week
- Protected against pregnancy by oral contraceptives, IUD, implant, contraceptive injections, patch, or sterilization
- Willing to use study condoms for ten vaginal intercourse acts within six weeks
- In a mutually monogamous relationship with study partner for at least 3 months and willing to remain so
- Agree not to use any vaginal or sexual lubricant except the study product
- Agree not to wear genital piercing jewelry while using study condoms
- Agree not to use sex toys or drugs to enhance or diminish sexual response during study
- Agree to return any unopened condoms
- Reachable by telephone
- Has home internet access, valid personal email for each partner, phone access, ability to videoconference and use electronic consent
- Male partner agrees to ejaculate during vaginal intercourse
- Willing to provide photo identification
You will not qualify if you...
- 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 polyisoprene or history of recurrent adverse events from these products
- Unable to follow instructions or adhere to visit schedule
- At high risk for sexually transmitted infections or history of serious recurrent STI
- Currently using condoms for protection against a known STI
- Taking internal or oral medication to treat a genital condition
- Male partner has had difficulty achieving or maintaining an erection or ejaculation in the last month under typical conditions
- Any self-reported genital condition that could affect condom use or study data interpretation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Essential Access
Berkeley, California, United States, 94710
Actively Recruiting
2
Essential Access
Los Angeles, California, United States, 90010-2648
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
PREVENTION
Number of Arms
2
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