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Evaluation of Synthetic Nitrile Male Condom Compared to Standard Latex Male Condom

NCT06079060 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 305

Last updated 2025-10-24

No results posted yet for this study

Summary

Thia is a multi-site, randomised 2-period cross-over trial comparing five uses of a 61 mm width synthetic nitrile male condom with five uses of a 61 mm width standard latex male condom.

Conditions

  • Sexually Transmitted Diseases

Interventions

DEVICE

Synthetic Nitrile Condom (61mm)

61mm width Synthetic Nitrile Condoms

DEVICE

Control Latex Condom

61mm width Natural Rubber Latex Condom

Sponsors & Collaborators

  • Match Research

    collaborator OTHER

  • Essential Access Health

    collaborator OTHER

  • Sigma3 Services SARL

    collaborator UNKNOWN

  • Karex Industries Sdn. Bhd.

    lead INDUSTRY

Principal Investigators

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

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
2023-10-06
Primary Completion
2024-09-30
Completion
2024-10-11
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 NCT06079060 on ClinicalTrials.gov