Okamoto Lubricated Synthetic Polyurethane Male Condom for Synthetic Polyurethane Male Condom

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Synthetic Polyurethane Male CondomCondom - Device
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

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.

Treatment Effectiveness

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 6 weeks

6 weeks
Adverse events
Clinical / Non-clinical slippage rates acceptability; and Adverse events
Clinical/non-clinical breakage rates
The total clinical failure rates for the test and control condoms
User acceptance

Trial Safety

Trial Design

2 Treatment Groups

Latex condom
1 of 2
Okamoto Lubricated Synthetic Polyurethane Male Condom
1 of 2

Active Control

Experimental Treatment

235 Total Participants · 2 Treatment Groups

Primary Treatment: Okamoto Lubricated Synthetic Polyurethane Male Condom · No Placebo Group · N/A

Okamoto Lubricated Synthetic Polyurethane Male Condom
Device
Experimental Group · 1 Intervention: Condom · Intervention Types: Device
Latex condom
Device
ActiveComparator Group · 1 Intervention: Condom · Intervention Types: Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Condom
2013
Completed Phase 1
~440

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 6 weeks

Who is running the clinical trial?

NAMSAOTHER
30 Previous Clinical Trials
13,272 Total Patients Enrolled
Okamoto Industries, Inc.Lead Sponsor

Eligibility Criteria

Age 18 - 65 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are sexually active and consent to engaging in adequate levels of penile-vaginal intercourse.
You have consented to the use of study-approved condoms during your involvement in the research.
You agree to abstain from using substances or implements that may alter sexual performance or affect the integrity of a condom.
You must have the capacity to comprehend guidance for proper usage of condoms.
You have no documented sexually transmitted infections, including HIV/AIDS.
You consent to utilizing solely the lubricants provided by this study.
You consent to returning any unopened condoms and lubricants.
You have committed to not wearing any intimate adornments while utilizing study prophylactics.
You are in a mutually exclusive, long-term relationship of at least three months.
You are between 18 and 65 years old.