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A Clinical Feasibility Study to Assess the Performance of a Latex Condom in Healthy Monogamous Couples.

NCT05073770 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-10-11

No results posted yet for this study

Summary

The U.S. Centers for Disease Control and Prevention has recommended the male latex condom as the best physical barrier for preventing HIV and sexually transmitted disease (STD) transmission. Condoms are a safe and effective form of contraception that have 98% effectiveness in protecting against STD and pregnancy. However, evidence shows that if a condom does not fit properly, its impact can reduce to 85% or less, as it may slip off during sex or during removal of the penis from the vagina or breaks during intercourse.

Condoms need to fit correctly to guard against fluids and exposed skin which could lead to STD contraction or pregnancy. To choose the right size, the girth (the width of an erect penis) is the most important factor, not length. However, most condom companies do not list their nominal width, let alone base their sizes off girth. In addition, most brands usually offer XL as only 56 mm based on a misconception that one size fits all and that "XL" condoms are big enough. But that is far from the truth, and several men complain about the lack of simplicity and intuitiveness when finding a condom that fits them.

To address this gap, after a long two years of development, Titan company was able to engineer four distinct sizes so that each man can easily find the condom he needs. This study aims to obtain a preliminary estimate of slippage and breakage of Titan's new condom (64mm or 69mm) during use.

Conditions

  • Performance of a New Condom

Interventions

DEVICE

Titan Condom

The test condoms have the following specifications throughout the study: 1. The plain 64mm condom (i.e., N64): Length 223 ±5mm, width 64±1mm, thickness (single wall) 0.070± 0.005mm, and beading thickness 1.25±0.05mm. 2. The plain 69mm condom (i.e., N69): Length 223 ±5mm, Width 69±1mm, Thickness (single wall) 0.070± 0.005mm, Beading thickness 1.25±0.05mm.

Sponsors & Collaborators

  • STATCure Consulting Services Inc.

    collaborator UNKNOWN

  • Titan Condoms, LLC

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-10-31
Primary Completion
2022-01-31
Completion
2022-03-31

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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 NCT05073770 on ClinicalTrials.gov