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

Part of paid clinical trials in Berkeley, California.

Sponsor
Thai Nippon Rubber Industry Public Company Limited
Study ID
NCT06595836
Status
Recruiting
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Conditions

  • Condom Use

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Silicone Lubricated Synthetic polyisoprine condom — DEVICE
    Synthetic polyisoprene condom are made from softer materials for a more natural feel and increased sensitivity
  • Silicone Lubricated Natural Rubber Latex Condom — DEVICE
    Natural rubber latex condoms are made from natural rubber

Study Details

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.

Key Dates

Start date
Jan 2, 2024
Status verified
Sep 2024
Primary completion
Dec 31, 2024
Completion
Feb 28, 2025

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION

Arms

  • Experimental: polyisoprene condoms lubricated with a silicone lubricant
    polyisoprene condoms lubricated with a silicone lubricant
  • Active Comparator: commercial latex condoms with a silicone lubricant
    commercial latex condoms with a silicone lubricant

Primary Outcome Measure

Total Clinical Failure [ Time Frame: 5 -7 weeks ]

Locations (2)

FacilityCityStateZIPSite coordinators
Essential AccessBerkeleyCalifornia94710
Terri Walsh, MPH
[email protected]
213-386-5614
Terri Walsh, MPH (PRINCIPAL_INVESTIGATOR)
Essential AccessLos AngelesCalifornia90010-2648
Terri Walsh, MPH
[email protected]
213-386-5614
Terri Walsh, MPH (PRINCIPAL_INVESTIGATOR)

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