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

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

Study Overview

• Status: Completed
• Conditions: Condom Use
• Intervention / Treatment: 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)

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.

• Study Type: Interventional
• Enrollment (Actual): 224
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Schenefeld, Germany
    • SGS proderm GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PU condom; 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); Participants will be provided with PU condoms (2 condoms per variant) to use during masturbation.
Experimental: NRL condom; 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); Participants will be provided with NRL condoms (2 condoms per variant) to use during masturbation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: Disagree, somewhat disagree, neither agree nor disagree, agree, strongly agree;; 1-10 with 1 being extremely dissatisfied and 10 being extremely satisfied.	6 weeks condom use period (intervention duration)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Examine whether the preferred condom variant is the same for both PU and NRL condoms.	The endpoint is the evaluation of the correspondence of preferred condom variant for PU and NRL condoms. The endpoint is collected over a period of 6 weeks on different condom types and variants by means of subject perceived questionnaires which participants will rate their condom preference using the following scales: Disagree, somewhat disagree, neither agree nor disagree, agree, strongly agree;; 1-10 with 1 being extremely dissatisfied and 10 being extremely satisfied.	6 weeks condom use period (intervention duration)

Collaborators and Investigators

• Sponsor: Reckitt Benckiser Healthcare (UK) Limited

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Actual): June 26, 2025
• Study Completion (Actual): June 26, 2025

Study Registration Dates

• First Submitted: January 10, 2025
• First Submitted That Met QC Criteria: January 10, 2025
• First Posted (Actual): January 16, 2025

Study Record Updates

• Last Update Posted (Actual): July 14, 2025
• Last Update Submitted That Met QC Criteria: July 9, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 5068701

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will be shared as per local regulations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No