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Evaluation of 2 Synthetic Nitrile Male Condoms Compared to a Standard Latex Male Condom

NCT05912283 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2024-05-28

No results posted yet for this study

Summary

This is a multi-site, randomised 3-period cross-over trial evaluating the functional performance of two synthetic nitrile male condoms against a control latex male condom.

Conditions

  • Sexually Transmitted Diseases

Interventions

DEVICE

Synthetic Nitrile Condoms (53mm)

53mm width synthetic nitrile condoms

DEVICE

Synthetic Nitrile Condoms (56mm)

56mm width synthetic nitrile condoms

DEVICE

Control Latex Condom

Commercial natural rubber latex condom

Sponsors & Collaborators

  • University of Witwatersrand, South Africa

    collaborator OTHER

  • Essential Access Health

    collaborator OTHER

  • Sigma3 Services SARL

    collaborator UNKNOWN

  • Karex Industries Sdn. Bhd.

    lead INDUSTRY

Principal Investigators

  • Mags Beksinska, PhD · MatCH Research Unit (MRU)

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
2023-06-02
Primary Completion
2024-01-31
Completion
2024-01-31
FDA Device
Yes

Countries

  • United States
  • South Africa

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 NCT05912283 on ClinicalTrials.gov