Clinical Study to Evaluate the Performance of Synthetic Polyurethane Male Condoms

A Randomized, Double-Blinded, Crossover and Multi-center Clinical Study to Evaluate the Performance of Synthetic Polyurethane Male Condom Compared to Standard Latex Condom During Vaginal Intercourse

This study is a randomized, double-blinded, crossover and multi-center study to evaluate the clinical breakage and slippage of a new synthetic polyurethane male condom compared to a commercially available standard latex condom.

Study Overview

• Status: Terminated
• Conditions: Performance of Synthetic Polyurethane Male Condom
• Intervention / Treatment: Device: Condom

Detailed Description

This study is a randomized, double-blinded, crossover and multi-center study to evaluate the clinical breakage and slippage of a new synthetic polyurethane male condom compared to a commercially available standard latex condom.

The duration of participation for each couple is approximately 6 weeks. Study subjects are given a set of one condom type to use for up to three consecutive weeks to complete each evaluation and then return for a set of the other condom type for another period of up to three weeks of evaluation.

The primary objective of this study is to determine whether the total clinical failure rate of a new test condom is comparable with the total clinical failure rate of a legally marketed latex condom when used during vaginal intercourse.

The secondary objective of this study is to evaluate the clinical slippage and breakage of the polyurethane and latex condoms, as well as user acceptance about using the devices and adverse events.

• Study Type: Interventional
• Enrollment (Actual): 188
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Mesa, Arizona, United States, 85209
      • Physicians Research Group
  • Florida
    • Miami, Florida, United States, 33176
      • Angels Clinical Research Center
  • Indiana
    • West Lafayette, Indiana, United States, 47906
      • Physicians Research Group
  • Ohio
    • Cincinnati, Ohio, United States, 45212
      • Wellnow

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Subjects are required to meet ALL of the following criteria for randomization into the study:

1. mutually monogamous, current relationship ≥ 3 months;
2. 18 years to 65 years of age;
3. sexually active, sufficient to meet protocol requirements; agree to have penile-vaginal intercourse with frequency sufficient to meet protocol requirements;
4. agree to use only study condoms during time of participation;
5. agree not to use drugs, ointments or non-study devices that can affect sexual performance or might affect the condom's physical property;
6. able to understand instructions for correct use of condoms;
7. no known sexually transmitted infections including HIV/AIDS;
8. agree to use only lubricant(s) provided by the study;
9. agree to return any unopened condoms and lubricants;
10. agree not to wear any genital piercing jewelry while using study condoms;

l) willing to use the study products for minimum of 10 acts of vaginal intercourse within 6 weeks of study entry; l) willing and capable of following requirements of protocol, including willingness to respond to questions about reproductive and contraceptive history and use of condoms during interviews; m) agree to use and has internet/web access in order to complete the Diaries and Surveys using iMedNet's ePRO module; n) available for follow-up and reachable by telephone.

Exclusion Criteria:

Subjects will be excluded in ANY of the following exclusion criteria apply at the time of entry or at the time during the study. If either partner is (or becomes) aware that:

1. he/she is allergic or sensitive to natural rubber latex or polyurethane,
2. female partner is pregnant or desires to become so while participating in study,
3. subject knowingly has a sexually transmitted infection,
4. commercial sex workers,
5. itinerant persons who cannot be able to complete the study, e.g. migrant farm workers,
6. male partner has known erectile or ejaculatory dysfunction,
7. either partner is using any medications or preparation applied topically or intravaginally to the genitalia other than that supplied for the study,
8. either partner is an employee of study sponsor, competitor or affiliated with clinical research center,
9. currently participating in another sexual health clinical study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Okamoto Lubricated Synthetic Polyurethane Male Condom; 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.	Device: Condom; Contraception
Active Comparator: Latex condom; Commercially available latex lubricated condom.	Device: Condom; Contraception

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The total clinical failure rates for the test and control condoms	The total clinical failure rate of a new test condom is comparable with the failure rate of a commercially available latex condom when used during vaginal intercourse as reported by study participant questionnaire.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical / Non-clinical slippage rates acceptability; and Adverse events	Evaluate the slippage rates of the polyurethane and the commercially available latex condom when used during vaginal intercourse, as reported by the study participant questionnaire.	6 weeks
Clinical/non-clinical breakage rates	Evaluate the breakage rates of the polyurethane and the commercially available latex condom when used during vaginal intercourse, as reported by the study participant questionnaire.	6 weeks
User acceptance	Evaluate the user acceptance rates of the polyurethane and the commercially available latex condom when used during vaginal intercourse, as reported by the study participant questionnaire.	6 weeks
Adverse events	Evaluate the number of adverse events of the polyurethane and the commercially available latex condom when used during vaginal intercourse, as reported by the study participant questionnaires and study Primary Investigators.	6 weeks

Collaborators and Investigators

• Sponsor: Okamoto Industries, Inc.
• Collaborators: NAMSA

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2022
• Primary Completion (Actual): July 12, 2023
• Study Completion (Actual): June 27, 2024

Study Registration Dates

• First Submitted: January 31, 2022
• First Submitted That Met QC Criteria: September 7, 2022
• First Posted (Actual): September 10, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 17, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: condom
• Other Study ID Numbers: 2022-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No