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Condom Performance in a Longitudinal Enhanced Assessment of User Experiences

NCT02753842 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 504

Last updated 2020-08-25

Study results available
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Summary

This study will enroll 252 men who have sex with men (MSM) and 252 men who have sex with women (MSW) in a double-blind, three-way randomized crossover trial with conditions of fitted, thin, and standard condoms. The study will provide fitted condoms in 56 sizes based on combinations of length (approximately 10 mm increments) and circumference (approximately 2 mm increments), with user-determined size based on a paper template measurement instrument.

Participants will be randomly assigned to the sequence in which the crossover intervention conditions (fitted, thin, and standard condoms) occur, with five study condoms provided for each condition. Participants will attend at least four, and up to seven, biweekly study visits.

Conditions

Interventions

DEVICE

5 Fitted Condoms, 5 Thin Condoms, 5 Standard Condoms

Fitted condoms are available in 56 sizes based on combinations of length (approximately 10mm increments) and circumference (approximately 2 mm increments). Fitted condom thickness is 70 microns ± 10 microns. Appropriate condom size is user-determined with a paper template fitting tool graduated with non-sequential numbering and lettering for maximum privacy. Participants also received ten plain foil packets of 10ml commercially available condom-compatible water-based lubricant. Thin condoms have dimensions of 185mm ± 10mm length, 53mm ± 2mm width, and 50 microns ± 5 microns thick. Participants also received ten plain foil packets of 10ml commercially available condom-compatible water-based lubricant. Standard condoms have dimensions of 185mm ± 10mm length, 53mm ± 2mm width, and 70 microns ± 10 microns thick. Participants also received ten plain foil packets of 10ml commercially available condom-compatible water-based lubricant.

Sponsors & Collaborators

  • Emory University

    collaborator OTHER

  • Global Protection Corp.

    lead INDUSTRY

Principal Investigators

  • Aaron J Siegler, PhD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
54 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2017-07-31
Completion
2017-07-31
FDA Device
Yes

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Diseases

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 NCT02753842 on ClinicalTrials.gov