Clinical trial NCT06777797: Prospective, Verification Study to Assess Condom Fit Across Polyurethane (PU) and Natural Rubber Latex (NRL) Condoms
Official title: Prospective, Verification Study to Assess Condom Fit Across Polyurethane (PU) and Natural Rubber Latex (NRL) Condoms
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Condom Use
Lead sponsor: Reckitt Benckiser Healthcare (UK) Limited
Sponsor class: INDUSTRY
First posted: 2025-01-16
Enrollment: 224
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: OTHER

Brief summary: 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.

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.

Primary outcomes:
measure: The exploration of condom experience across a range of sizes and materials
timeFrame: 6 weeks condom use period (intervention duration)
Secondary outcomes:
measure: Examine whether the preferred condom variant is the same for both PU and NRL condoms.
timeFrame: 6 weeks condom use period (intervention duration)
Other outcomes:
Locations:
city: Schenefeld
country: Germany
facility: SGS proderm GmbH
Study officials:
References: