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

NCT06595836 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2024-09-19

No results posted yet for this study

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.

Conditions

  • Condom Use

Interventions

DEVICE

Silicone Lubricated Synthetic polyisoprine condom

Synthetic polyisoprene condom are made from softer materials for a more natural feel and increased sensitivity

DEVICE

Silicone Lubricated Natural Rubber Latex Condom

Natural rubber latex condoms are made from natural rubber

Sponsors & Collaborators

  • Thai Nippon Rubber Industry Public Company Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-02
Primary Completion
2024-12-31
Completion
2025-02-28
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06595836 on ClinicalTrials.gov