Assessing condom fit and comfort with different materials and sizes

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

This study tests how comfortable and well-fitting different types and sizes of condoms are for experienced users to see which ones they like best.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 224 (estimated)
• Ages: 18 Years to 55 Years
• Sex: Male
• Sponsor: Reckitt Benckiser Healthcare (UK) Limited (Industry-sponsored)
• Locations: 1 site (Schenefeld)
• Trial ID: NCT06777797 on ClinicalTrials.gov

What this trial studies

This investigation evaluates the experience of condom users regarding comfort and fit by testing eight different condom variants, four made from Polyurethane (PU) and four from Natural Rubber Latex (NRL). Participants, who are experienced condom users, will engage in self-stimulation while using these condoms to provide feedback on their experience. The study aims to gather data on how different materials and sizes affect user satisfaction and performance. The findings could inform future condom design and recommendations for users.

Who should consider this trial

Good fit: Ideal candidates for this study are cisgender males aged 18 to 55 who are experienced condom users and can achieve an erection.

Not a fit: Patients who have difficulty attaining or maintaining an erection or have clinically abnormal findings on the penis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved condom designs that enhance user comfort and satisfaction, potentially increasing condom usage and reducing the risk of STIs and unintended pregnancies.

How similar studies have performed: While there have been studies on condom materials and user experience, this specific approach to systematically assess fit and comfort across multiple variants is relatively novel.

Eligibility 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.

Where this trial is running

Schenefeld

• SGS proderm GmbH — Schenefeld, Germany (Recruiting)

Study contacts

• Study coordinator: Site Project Manager

Conditions Condom Use