Prospective, Verification Study to Assess Condom Fit Across Polyurethane (PU) and Natural Rubber Latex (NRL) Condoms

Reckitt Benckiser

Status: Completed

Conditions: Condom Use

Treatments: Device: PU condoms (Test PU Condom A, Test PU Condom B, Test PU Condom C, Test PU Condom D); Device: NRL condoms (Test NRL Condom A, Test NRL Condom B, Test NRL Condom C, Test NRL Condom D)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06777797

5068701

Details and patient eligibility

About

The investigation is to explore condom experience in terms of comfort and fit across a range of condom sizes and materials.

Full 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.

Enrollment: 224 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Signed written informed consent before participation in the clinical investigation.
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.

Key Exclusion Criteria:

1. Participants with known trouble attaining or maintaining an erection.
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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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224 participants in 2 patient groups

PU condom

Experimental group

Description:

Following randomization, participants will test PU condoms first followed by NRL condoms.

Treatment:

Device: PU condoms (Test PU Condom A, Test PU Condom B, Test PU Condom C, Test PU Condom D)

NRL condom

Experimental group

Description:

Following randomization, participants will test NRL condoms first followed by PU condoms.

Treatment:

Device: NRL condoms (Test NRL Condom A, Test NRL Condom B, Test NRL Condom C, Test NRL Condom D)