Clinical Study to Evaluate the Performance of Synthetic Polyurethane Male Condoms

NCT05536336 | Terminated FDA Device

• 1 other identifier: 2022-06
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Performance of Synthetic Polyurethane Male Condom

Keywords

condom

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Clinical / Non-clinical slippage rates acceptability; and Adverse events

  6 weeks

• Clinical/non-clinical breakage rates

  6 weeks

• User acceptance

  6 weeks

• Adverse events

  6 weeks

Study Arms (2)

Okamoto Lubricated Synthetic Polyurethane Male Condom

EXPERIMENTAL

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

Latex condom

ACTIVE COMPARATOR

Commercially available latex lubricated condom.

Device: Condom

Interventions

Condom DEVICE

Contraception

Latex condom; Okamoto Lubricated Synthetic Polyurethane Male Condom

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects are required to meet ALL of the following criteria for randomization into the study:
• mutually monogamous, current relationship ≥ 3 months;
• years to 65 years of age;
• sexually active, sufficient to meet protocol requirements; agree to have penile-vaginal intercourse with frequency sufficient to meet protocol requirements;
• agree to use only study condoms during time of participation;
• agree not to use drugs, ointments or non-study devices that can affect sexual performance or might affect the condom's physical property;
• able to understand instructions for correct use of condoms;
• no known sexually transmitted infections including HIV/AIDS;
• agree to use only lubricant(s) provided by the study;
• agree to return any unopened condoms and lubricants;
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Okamoto Industries, Inc.: lead
• NAMSA: collaborator

Study Sites (4)

Physicians Research Group

Mesa, Arizona, 85209, United States

Location

Angels Clinical Research Center

Miami, Florida, 33176, United States

Location

Physicians Research Group

West Lafayette, Indiana, 47906, United States

Location

Wellnow

Cincinnati, Ohio, 45212, United States

Location

MeSH Terms

Interventions

Condoms

Intervention Hierarchy (Ancestors)

Contraceptive Devices, Male; Contraceptive Devices; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: September 10, 2022
• Study Start: September 8, 2022
• Primary Completion: July 12, 2023
• Study Completion: June 27, 2024
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)