Prospective, Verification Study to Assess Condom Fit Across Polyurethane (PU) and Natural Rubber Latex (NRL) Condoms
NCT ID: NCT06777797
Last Updated: 2025-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
224 participants
INTERVENTIONAL
2025-04-01
2025-06-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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PU condom
Following randomization, participants will test PU condoms first followed by NRL condoms.
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.
NRL condom
Following randomization, participants will test NRL condoms first followed by PU condoms.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
2. Cisgender male, aged 18 - 55 years.
3. In the opinion of Investigator, experienced user of condoms who use condoms to prevent pregnancies and / or contracting STIs.
4. Able and willing to achieve a penile erection following self-stimulation.
5. Able and willing to masturbate with a PU or NRL condom on.
6. Agree to use only lubricant provided by the study for use with IMDs, if required.
7. Agree not to wear any genital piercing jewelry while using the study condoms.
8. Agree not to use sex toys, consume alcohol or use drugs intended to enhance or diminish sexual response when using study condoms.
9. Agree to perform erected penis size measurement at site and at home.
Exclusion Criteria
2. Participants presenting clinically abnormal findings on the penis that in the opinion of the investigator can affect the study outcome.
3. Participants with an allergy or sensitivity to the ingredients of the test products, including the test condoms or any lubrication products provided.
4. Use of any topical medications applied to the penis between screening and visit 3.
5. Participants with diagnosed or suspected erectile dysfunction.
6. Participants with a history of prostatectomy.
7. Participants with a history of urethral surgery.
8. Participants with any other congenital or acquired genital abnormalities (e.g. peyronies disease, hypospadias, intersex, phimosis, penile cancer).
9. 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.
10. 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.
11. Participants who should not participate in the clinical investigation for any other reason as judged by the investigator.
12. 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.
13. Employees of the investigation sites who are directly involved in this clinical investigation or employees of the sponsor's company.
18 Years
55 Years
MALE
Yes
Sponsors
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Reckitt Benckiser Healthcare (UK) Limited
INDUSTRY
Responsible Party
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Locations
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SGS proderm GmbH
Schenefeld, , Germany
Countries
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Other Identifiers
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5068701
Identifier Type: -
Identifier Source: org_study_id
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