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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new synthetic condom with sexually active couples to see if it works as well as standard latex condoms in preventing breakage and slippage. Some studies have shown that synthetic condoms may break more often than latex ones.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The total clinical failure rates for the test and control condoms
Secondary study objectives
Adverse events
Clinical / Non-clinical slippage rates acceptability; and Adverse events
Clinical/non-clinical breakage rates
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
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Who is running the clinical trial?
Okamoto Industries, Inc.Lead Sponsor
NAMSAOTHER
52 Previous Clinical Trials
20,505 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have an allergy or sensitivity to natural rubber latex or polyurethane.You understand how to use condoms correctly.The male partner has a known problem with getting or maintaining an erection or with ejaculating.You or your partner are using any medications or creams on your genital area, except those provided by the study.People who work as prostitutes.You are willing to use the study products for at least 10 acts of vaginal intercourse within 6 weeks of starting the study.
Research Study Groups:
This trial has the following groups:- Group 1: Okamoto Lubricated Synthetic Polyurethane Male Condom
- Group 2: Latex condom
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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