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

NCT06777797 | Completed

• 1 other identifier: 5068701
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Condom Use

Outcome Measures

Primary Outcomes (1)

• The exploration of condom experience across a range of sizes and materials

  Participants will measure their penis size at screening and will be assigned to pre-defined groups. The endpoint is the exploration of condom experience across a range of materials and sizes within each group. Participants will evaluate the condoms over a period of 6 weeks and rate their condom experience through subject perceived questionnaires using the following scales: 1. Disagree, somewhat disagree, neither agree nor disagree, agree, strongly agree; 2. 1-10 with 1 being extremely dissatisfied and 10 being extremely satisfied.

  6 weeks condom use period (intervention duration)

Secondary Outcomes (1)

• Examine whether the preferred condom variant is the same for both PU and NRL condoms.

  6 weeks condom use period (intervention duration)

Study Arms (2)

PU condom

EXPERIMENTAL

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

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

NRL condom

EXPERIMENTAL

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

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

Interventions

PU condoms (Test PU Condom A, Test PU Condom B, Test PU Condom C, Test PU Condom D) DEVICE

Participants will be provided with PU condoms (2 condoms per variant) to use during masturbation.

PU condom

NRL condoms (Test NRL Condom A, Test NRL Condom B, Test NRL Condom C, Test NRL Condom D) DEVICE

Participants will be provided with NRL condoms (2 condoms per variant) to use during masturbation.

NRL condom

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Cisgender male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Reckitt Benckiser Healthcare (UK) Limited: lead

Study Sites (1)

SGS proderm GmbH

Schenefeld, Germany

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Although it is an open label investigation, some information such as condom size will be removed from all packages so participants will not know which condom variant they are testing.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 16, 2025
• Study Start: April 1, 2025
• Primary Completion: June 26, 2025
• Study Completion: June 26, 2025
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)