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Clinical Study to Evaluate the Performance of Synthetic Polyurethane Male Condoms

NCT05536336 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2025-03-20

No results posted yet for this study

Summary

This study is a randomized, double-blinded, crossover and multi-center study to evaluate the clinical breakage and slippage of a new synthetic polyurethane male condom compared to a commercially available standard latex condom.

Conditions

  • Performance of Synthetic Polyurethane Male Condom

Interventions

DEVICE

Condom

Contraception

Sponsors & Collaborators

  • NAMSA

    collaborator OTHER

  • Okamoto Industries, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2022-09-08
Primary Completion
2023-07-12
Completion
2024-06-27
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 NCT05536336 on ClinicalTrials.gov