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The investigation is to explore condom experience in terms of comfort and fit across a range of condom sizes and materials.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PU condom | Experimental | Following randomization, participants will test PU condoms first followed by NRL condoms. |
|
| NRL condom | Experimental | Following randomization, participants will test NRL condoms first followed by PU condoms. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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:
| 6 weeks condom use period (intervention duration) |
| 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:
|
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Inclusion Criteria:
Key Exclusion Criteria:
Cisgender male
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS proderm GmbH | Schenefeld | Germany |
IPD will be shared as per local regulations.
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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.
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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.
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| 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. |
|
| 6 weeks condom use period (intervention duration) |