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Evaluation of Polyurethane Male Condoms

NCT04622306 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2023-10-06

Study results available
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Summary

The clinical study will compare two lubricated polyurethane male condoms of different thickness with a marketed lubricated control male condom made of natural rubber latex. This crossover study will randomize 300 heterosexual couples to the sequence in which they use five condoms of each of the three study condom types. The clinical failure (breakage and slippage) rates of the two polyurethane condoms will be compared to the clinical failure (breakage and slippage) rate of commercial natural rubber latex control condom using a statistical test of non-inferiority. The study will also compare the acceptability of the two polyurethane condom different thickness with that of the natural rubber latex control condom obtained from interviews and questionnaires with subject couples.

Conditions

  • Contraception
  • Prevention of Sexually Transmitted Infections

Interventions

DEVICE

Control Latex Condom C, Polyurethane Condom A, Polyurethane Condom B

Condom functionality study to determine failure rates

Sponsors & Collaborators

  • Essential Access Health

    collaborator OTHER

  • Sagami Rubber Industries Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Grant R Burt · Sagami Rubber Industries Co., Ltd.

  • William D Potter, PhD · Stapleford Scientific Services Limited

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
2020-10-12
Primary Completion
2021-12-06
Completion
2021-12-30
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 NCT04622306 on ClinicalTrials.gov