ClinicalTrials.gg
CompletedNCT06777797Updated Jul 14, 2025

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

An interventional study of PU condoms (Test PU Condom A, Test PU Condom B, Test PU Condom C, Test PU Condom D) and NRL condoms (Test NRL Condom A, Test NRL Condom B, Test NRL Condom C, Test NRL Condom D) in Condom Use, sponsored by Reckitt Benckiser Healthcare (UK) Limited. Completed at 1 site in Germany. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-14.

Sponsored by Reckitt Benckiser Healthcare (UK) Limited (part of Reckitt) · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
224
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Male
01

Study summary

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

Read the 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.

02

Conditions studied

  • Condom Use
03

In context

Lead sponsor

Reckitt Benckiser Healthcare (UK) Limited is the lead sponsor of 35 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:

  1. Signed written 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 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
224 participants (actual)

Study arms

  • 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)

  • 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)

Interventions

  • DevicePU 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.

  • DeviceNRL 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.

06

What researchers measure

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.

    Time frame: 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.

    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: 1. Disagree, somewhat disagree, neither agree nor disagree, agree, strongly agree; 2. 1-10 with 1 being extremely dissatisfied and 10 being extremely satisfied.

    Time frame: 6 weeks condom use period (intervention duration)

07

Study locations

1 site
  • SGS proderm GmbH
    Schenefeld, Germany
08

References and documents

Individual participant data

Plan to share: No — IPD will be shared as per local regulations.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2025 to primary completion in Jun 2025, 2 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 10, 2025
First posted
Jan 16, 2025
StartActual
Apr 1, 2025
Primary completionActual
Jun 26, 2025
CompletionActual
Jun 26, 2025
Last update
Jul 14, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06777797
Responsible party
Sponsor
First posted
Jan 16, 2025
Start date
Apr 1, 2025
Primary completion
Jun 26, 2025
Completion
Jun 26, 2025
Last update
Jul 14, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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