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

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.

Inclusion criteria

• 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.
• 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.

Key Exclusion Criteria:

• 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.
• 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.