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Synthetic Male Condom Slippage-Breakage Study

NCT05370196 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2023-11-08

No results posted yet for this study

Summary

This is a multi-site, double-blind, crossover, randomized phase II study to evaluate the functional performance of a synthetic male condom as compared to a marketed latex condom.

Conditions

  • Contraceptive
  • Sexually Transmitted Diseases

Interventions

DEVICE

Test Product

Synthetic Male Condom

DEVICE

Control Product

Latex Male Condom

Sponsors & Collaborators

  • Essential Access Health

    collaborator OTHER

  • Church & Dwight Company, Inc.

    lead INDUSTRY

Principal Investigators

  • Terri Walsh, MPH · Essential Access Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2022-06-10
Primary Completion
2023-01-13
Completion
2023-05-12
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 NCT05370196 on ClinicalTrials.gov