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

ConditionCondom Use
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorThai Nippon Rubber Industry Public Company Limited

About this trial

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.

Eligibility criteria

Qualifiers

Between the ages of 18 and 45 (inclusive)

Willing and able to give written or electronic informed consent

Willing to respond to questions concerning their reproductive and contraceptive history and use of condoms contained either on self-administered questionnaires or interviews

Be sexually active (defined as averaging one vaginal coital act per week)

Disqualifiers

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 has a history of recurrent adverse events following use of latex or polyisoprene products

Unable to follow instructions or strictly adhere to the visit schedule

Trial design

Treatments tested in this trial

  • Silicone Lubricated Synthetic polyisoprine condom
  • Silicone Lubricated Natural Rubber Latex Condom

Treatment groups

300 Participants
are divided into 2 treatment groups