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Polyurethane Condom

Okamoto Lubricated Synthetic Polyurethane Male Condom for Synthetic Polyurethane Condom

N/A
Waitlist Available
Research Sponsored by Okamoto Industries, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
able to understand instructions for correct use of condoms
willing to use the study products for minimum of 10 acts of vaginal intercourse within 6 weeks of study entry
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights

Study Summary

This trial is testing a new kind of condom against a standard one to see which is better at preventing breakage and slippage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You understand how to use condoms correctly.
Select...
You are willing to use the study products for at least 10 acts of vaginal intercourse within 6 weeks of starting the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The total clinical failure rates for the test and control condoms
Secondary outcome measures
Adverse events
Clinical / Non-clinical slippage rates acceptability; and Adverse events
Clinical/non-clinical breakage rates
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Okamoto Lubricated Synthetic Polyurethane Male CondomExperimental Treatment1 Intervention
The test device name is Okamoto 001 Lubricated Polyurethane Male Condom. The condom is made in Japan and conforms to ASTM D6324-11 (2017) Standard Test Methods for Male Condoms Made from Polyurethane.
Group II: Latex condomActive Control1 Intervention
Commercially available latex lubricated condom.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Condom
2013
Completed Phase 1
~110

Find a Location

Who is running the clinical trial?

NAMSAOTHER
43 Previous Clinical Trials
16,307 Total Patients Enrolled
Okamoto Industries, Inc.Lead Sponsor

Media Library

Synthetic Polyurethane Male Condom (Polyurethane Condom) Clinical Trial Eligibility Overview. Trial Name: NCT05536336 — N/A
Synthetic Polyurethane Condom Research Study Groups: Latex condom, Okamoto Lubricated Synthetic Polyurethane Male Condom
Synthetic Polyurethane Condom Clinical Trial 2023: Synthetic Polyurethane Male Condom Highlights & Side Effects. Trial Name: NCT05536336 — N/A
Synthetic Polyurethane Male Condom (Polyurethane Condom) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05536336 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the enrollment number for this trial?

"Affirmative. The information hosted on clinicaltrials.gov reveals that the trial commenced recruiting participants on September 8th 2022 and underwent its last update on October 4th 2022. This medical research requires 235 people to be enrolled from 3 different centres of care."

Answered by AI

Could adults older than 18 years of age participate in this experiment?

"This clinical trial is open to patients aged 18 and over, provided they are younger than 50."

Answered by AI

Is this clinical assessment currently recruiting participants?

"Affirmative. Clinicaltrials.gov hosts data which verifies that this trial, initially posted on September 8th 2022 is currently enrolling patients. There are 235 positions to fill between 3 separate medical sites."

Answered by AI

Does my health profile meet the requisites for this research project?

"This clinical trial seeks 235 individuals aged 18 to 50 that have been exposed to isophorone polyurethane. Eligibility criteria for candidates include: a monogamous relationship of at least three months, no known sexually transmitted infections such as AIDS/HIV, agreement not to use any drugs or substances besides those supplied by the study and ability to understand instructions on condom usage, contraceptive measures already in place (e.g., oral contraceptives), active sexual life according to protocol requirements, consenting only to utilize the condoms and lubricants provided during participation, willingness to return unopened safety materials upon completion of follow-up period."

Answered by AI
~94 spots leftby Mar 2025