Condom UseNCT06777797
Prospective, Verification Study to Assess Condom Fit Across Polyurethane (PU) and Natural Rubber Latex (NRL) Condoms
A study testing PU condoms (Test PU Condom A, Test PU Condom B, Test PU Condom C, Test PU Condom D) and NRL condoms (Test NRL Condom A, Test NRL Condom B, Test NRL Condom C, Test NRL Condom D) in people with Condom Use, run by Reckitt Benckiser Healthcare (UK) Limited at 1 site in Germany.
Trial summary
The investigation is to explore condom experience in terms of comfort and fit across a range of condom sizes and materials. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Condom Use
- What is being tested?
- PU condoms (Test PU Condom A, Test PU Condom B, Test PU Condom C, Test PU Condom D) and NRL condoms (Test NRL Condom A, Test NRL Condom B, Test NRL Condom C, Test NRL Condom D)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2025to 26 Jun 2025
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed written informed consent before participation in the clinical investigation.
- Cisgender male, aged 18 - 55 years.
- In the opinion of Investigator, experienced user of condoms who use condoms to prevent pregnancies and / or contracting STIs.
- Able and willing to achieve a penile erection following self-stimulation.
- Able and willing to masturbate with a PU or NRL condom on.
- Agree to use only lubricant provided by the study for use with IMDs, if required.
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- Agree not to wear any genital piercing jewelry while using the study condoms.
- Agree not to use sex toys, consume alcohol or use drugs intended to enhance or diminish sexual response when using study condoms.
- Agree to perform erected penis size measurement at site and at home.
Who cannot join
- Participants with known trouble attaining or maintaining an erection.
- Participants presenting clinically abnormal findings on the penis that in the opinion of the investigator can affect the study outcome.
- Participants with an allergy or sensitivity to the ingredients of the test products, including the test condoms or any lubrication products provided.
- Use of any topical medications applied to the penis between screening and visit 3.
- Participants with diagnosed or suspected erectile dysfunction.
- Participants with a history of prostatectomy.
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- Participants with a history of urethral surgery.
- Participants with any other congenital or acquired genital abnormalities (e.g. peyronies disease, hypospadias, intersex, phimosis, penile cancer).
- Psychiatric conditions that might limit the participation in the clinical investigation and/or that lead to the assumption that the ability to completely understand the consequences of consent is missing.
- Participants with any medical condition in the opinion of the investigator which poses a risk to the participant or is detrimental to the objectives of the clinical investigation.
- Participants who should not participate in the clinical investigation for any other reason as judged by the investigator.
- Participation in a pharmaceutical trial with investigational products or in a clinical investigation with another medical device within the last 30 days prior to the visit 2 (day 1) and / or during this clinical investigation.
- Employees of the investigation sites who are directly involved in this clinical investigation or employees of the sponsor's company.
Trial locations and contacts
1 site in 1 country.
About this study
The investigation is to explore condom experience in terms of comfort and fit across a range of condom sizes and materials.
Read the detailed description
In this investigation, 4 Polyurethane (PU) condom variants and 4 Natural Rubber Latex (NRL) condom variants will be tested by participants to explore condom experience.
- Conditions
- Condom Use
- Being tested
- PU condoms (Test PU Condom A, Test PU Condom B, Test PU Condom C, Test PU Condom D), NRL condoms (Test NRL Condom A, Test NRL Condom B, Test NRL Condom C, Test NRL Condom D)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PU condoms (Test PU Condom A, Test PU Condom B, Test PU Condom C, Test PU Condom D)Device
Participants will be provided with PU condoms (2 condoms per variant) to use during masturbation.
NRL condoms (Test NRL Condom A, Test NRL Condom B, Test NRL Condom C, Test NRL Condom D)Device
Participants will be provided with NRL condoms (2 condoms per variant) to use during masturbation.
| Study group | Role | What they receive |
|---|---|---|
| PU condom | Experimental | Following randomization, participants will test PU condoms first followed by NRL condoms. Receives: Device: PU condoms (Test PU Condom A, Test PU Condom B, Test PU Condom C, Test PU Condom D) |
| NRL condom | Experimental | Following randomization, participants will test NRL condoms first followed by PU condoms. Receives: Device: NRL condoms (Test NRL Condom A, Test NRL Condom B, Test NRL Condom C, Test NRL Condom D) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The exploration of condom experience across a range of sizes and materials
Participants will measure their penis size at screening and will be assigned to pre-defined groups. The endpoint is the exploration of condom experience across a range of materials and sizes within each group. Participants will evaluate the condoms over a period of 6 weeks and rate their condom experience through subject perceived questionnaires using the following scales:
- Disagree, somewhat disagree, neither agree nor disagree, agree, strongly agree;
- 1-10 with 1 being extremely dissatisfied and 10 being extremely satisfied.
Measured: 6 weeks condom use period (intervention duration)
Secondary outcomes (1)
Examine whether the preferred condom variant is the same for both PU and NRL condoms.
The endpoint is the evaluation of the correspondence of preferred condom variant for PU and NRL condoms. The endpoint is collected over a period of 6 weeks on different condom types and variants by means of subject perceived questionnaires which participants will rate their condom preference using the following scales:
- Disagree, somewhat disagree, neither agree nor disagree, agree, strongly agree;
- 1-10 with 1 being extremely dissatisfied and 10 being extremely satisfied.
Measured: 6 weeks condom use period (intervention duration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start1 Apr 2025
- Primary completion26 Jun 2025
- Study completion26 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Condom UseStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a prospective, open-label, intra-individual, exploratory, single-centre clinical investigation. Each participant will test 4 PU condoms and 4 NRL condoms in a defined order, according to the randomization schedule.
- Masking
- None (open label)
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reckitt Benckiser Healthcare (UK) Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06777797
- Sponsor's protocol ID
- 5068701
- Status last verified
- Jul 2025
- First submitted
- 10 Jan 2025
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be shared as per local regulations.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Verification Study to Assess Condom Fit Across Polyurethane (PU) and Natural Rubber Latex (NRL) Condoms
- ClinicalTrials.gov ID
- NCT06777797
- Acronym / sponsor ID
- 5068701
- Conditions
- Condom Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Reckitt Benckiser Healthcare (UK) LimitedIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 26 Jun 2025 (actual)
- Study completion
- 26 Jun 2025 (actual)
- First posted
- 16 Jan 2025 (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.
The investigation is to explore condom experience in terms of comfort and fit across a range of condom sizes and materials.
Detailed description
In this investigation, 4 Polyurethane (PU) condom variants and 4 Natural Rubber Latex (NRL) condom variants will be tested by participants to explore condom experience.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective, open-label, intra-individual, exploratory, single-centre clinical investigation. Each participant will test 4 PU condoms and 4 NRL condoms in a defined order, according to the randomization schedule.
| Arm | Type | Receives |
|---|---|---|
| PU condom | Experimental | Device: PU condoms (Test PU Condom A, Test PU Condom B, Test PU Condom C, Test PU Condom D)Following randomization, participants will test PU condoms first followed by NRL condoms. |
| NRL condom | Experimental | Device: NRL condoms (Test NRL Condom A, Test NRL Condom B, Test NRL Condom C, Test NRL Condom D)Following randomization, participants will test NRL condoms first followed by PU condoms. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Signed written informed consent before participation in the clinical investigation.
- Cisgender male, aged 18 - 55 years.
- In the opinion of Investigator, experienced user of condoms who use condoms to prevent pregnancies and / or contracting STIs.
- Able and willing to achieve a penile erection following self-stimulation.
- Able and willing to masturbate with a PU or NRL condom on.
Key exclusion criteria (13 listed)
- Participants with known trouble attaining or maintaining an erection.
- Participants presenting clinically abnormal findings on the penis that in the opinion of the investigator can affect the study outcome.
- Participants with an allergy or sensitivity to the ingredients of the test products, including the test condoms or any lubrication products provided.
- Use of any topical medications applied to the penis between screening and visit 3.
- Participants with diagnosed or suspected erectile dysfunction.
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 |
|---|---|---|
| PU condoms (Test PU Condom A, Test PU Condom B, Test PU Condom C, Test PU Condom D)Participants will be provided with PU condoms (2 condoms per variant) to use during masturbation. | Device | PU condom |
| NRL condoms (Test NRL Condom A, Test NRL Condom B, Test NRL Condom C, Test NRL Condom D)Participants will be provided with NRL condoms (2 condoms per variant) to use during masturbation. | Device | NRL condom |
Primary outcome
The exploration of condom experience across a range of sizes and materials
Time frame: 6 weeks condom use period (intervention duration)
Participants will measure their penis size at screening and will be assigned to pre-defined groups. The endpoint is the exploration of condom experience across a range of materials and sizes within each group. Participants will evaluate the condoms over a period of 6 weeks and rate their condom experience through subject perceived questionnaires using the following scales: 1. Disagree, somewhat disagree, neither agree nor disagree, agree, strongly agree; 2. 1-10 with 1 being extremely dissatisfied and 10 being extremely satisfied.
1 secondary outcome
Examine whether the preferred condom variant is the same for both PU and NRL condoms.
Time frame: 6 weeks condom use period (intervention duration)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Individual participant dataSharing planned: No. IPD will be shared as per local regulations.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PU condoms (Test PU Condom A, Test PU Condom B, Test PU Condom C, Test PU Condom D) and NRL condoms (Test NRL Condom A, Test NRL Condom B, Test NRL Condom C, Test NRL Condom D) in people with Condom Use, run by Reckitt Benckiser Healthcare (UK) Limited at 1 site in Germany.
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 9 inclusion and 13 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: finished, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 exploration of condom experience across a range of sizes and materials (time frame: 6 weeks condom use period (intervention duration)). 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 14 Jul 2025.