Evaluation of the Performance and Acceptability of a Synthetic Polyisoprene Male Condom Compared to a Natural Rubber Latex Condom (Phase II Slippage/Breakage Study)
Thai Nippon Rubber Industry Public Company Limited
Summary
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.
Description
Three hundred (300) couples will be enrolled and asked to use five condoms of each of the two types of lubricated condoms to yield a potential sample size of 1500 uses for each type of lubricated condom. To minimize a potential learning effect, couples will be randomly assigned to the sequence of use of each type of lubricated condom. The primary objective of this study is to examine the slippage, breakage and acceptability of a new polyisoprene male condom compared to a natural rubber latex condom. The study will assess safety in terms of adverse events and user acceptability will be evaluat…
Eligibility
- Age range
- 18–45 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion 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…
Interventions
- DeviceSilicone Lubricated Synthetic polyisoprine condom
Synthetic polyisoprene condom are made from softer materials for a more natural feel and increased sensitivity
- DeviceSilicone Lubricated Natural Rubber Latex Condom
Natural rubber latex condoms are made from natural rubber
Locations (2)
- Essential AccessBerkeley, California
- Essential AccessLos Angeles, California