Performance of Synthetic Polyurethane Male CondomNCT05536336
Clinical Study to Evaluate the Performance of Synthetic Polyurethane Male Condoms
A study testing Condom in people with Performance of Synthetic Polyurethane Male Condom, run by Okamoto Industries, Inc. at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Performance of Synthetic Polyurethane Male Condom
- What is being tested?
- Condom
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 4 sitesUnited States
- Study dates
- 8 Sep 2022to 27 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects are required to meet ALL of the following criteria for randomization into the study:
- mutually monogamous, current relationship ≥ 3 months;
- 18 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;
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- 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;
- 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.
Who cannot join
- 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:
- 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,
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- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Wellnow
Cincinnati, Ohio, 45212
Physicians Research Group
Mesa, Arizona, 85209
Angels Clinical Research Center
Miami, Florida, 33176
Physicians Research Group
West Lafayette, Indiana, 47906
About this study
Official title: 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.
Read the 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.
- Being tested
- Condom
- Keywords
- condom
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CondomDevice
Contraception
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Condom |
| Latex condom | Active comparator | Commercially available latex lubricated condom. Receives: Device: Condom |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start8 Sep 2022
- Primary completion12 Jul 2023
- Study completion27 Jun 2024
Why it stopped: Sponsor has opted to discontinue the study due to site non-compliance.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Performance of Synthetic Polyurethane Male CondomStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Okamoto Industries, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NAMSA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05536336
- Sponsor's protocol ID
- 2022-06
- Status last verified
- Mar 2025
- First submitted
- 31 Jan 2022
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05536336
- Acronym / sponsor ID
- 2022-06
- Keywords
- condom
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor has opted to discontinue the study due to site non-compliance.
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Okamoto Industries, Inc.Industry (pharma, biotech, devices)
- Collaborators
- NAMSA
- Study start
- 8 Sep 2022 (actual)
- Primary completion
- 12 Jul 2023 (actual)
- Study completion
- 27 Jun 2024 (actual)
- First posted
- 10 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Okamoto Lubricated Synthetic Polyurethane Male Condom | Experimental | Device: CondomThe 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. |
| Latex condom | Active comparator | Device: CondomCommercially available latex lubricated condom. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subjects are required to meet ALL of the following criteria for randomization into the study:
- mutually monogamous, current relationship ≥ 3 months;
- 18 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;
Key exclusion criteria (10 listed)
- 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:
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CondomContraception | Device | Latex condom, Okamoto Lubricated Synthetic Polyurethane Male Condom |
Primary outcome
The total clinical failure rates for the test and control condoms
Time frame: 6 weeks
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.
4 secondary outcomes
Clinical / Non-clinical slippage rates acceptability; and Adverse events
Time frame: 6 weeks
Clinical/non-clinical breakage rates
Time frame: 6 weeks
User acceptance
Time frame: 6 weeks
Adverse events
Time frame: 6 weeks
Results and safety
The study was stopped early (reason given: Sponsor has opted to discontinue the study due to site non-compliance.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Condom in people with Performance of Synthetic Polyurethane Male Condom, run by Okamoto Industries, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Sponsor has opted to discontinue the study due to site non-compliance.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The total clinical failure rates for the test and control condoms (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.