Ignite Creation Date:
2024-10-25 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06557499
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-24
Brief Title:
A 3-way Crossover Clinical Investigation to Assess the Performance of Two Different Sized Polyurethane Condoms Versus a Latex Condom in Healthy Monogamous Couples
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Data Analyst-masked 3-way Cross-over Pivotal Clinical Investigation to Evaluate the Performance of Two Polyurethane Male Condoms With Different Size and Thickness in Healthy Monogamous Couples During Vaginal Intercourse Compared With a Commercially Available Thin Latex Male Condom
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This investigation is designed to evaluate the performance rate of two polyurethane male condoms with different sizes and thicknesses versus a standard natural rubber latex NRL male condom
The purpose of this study is to see how well the experimental condoms perform compared to the latex rubber condom for example how often the different condom types break or slip off the penis
Sponsor also wants to find out how well couples like using the three condom types and whether they experience any problems when using the condoms for example irritation or discomfort
The purpose of this study is to see how well the experimental condoms perform compared to the latex rubber condom for example how often the different condom types break or slip off the penis
Sponsor also wants to find out how well couples like using the three condom types and whether they experience any problems when using the condoms for example irritation or discomfort
Detailed Description:
In this clinical investigation new two PU male condoms test condoms will be evaluated against a marketed NRL male condom control condom This clinical investigation will also evaluate the in-use tolerance of the test and control condoms
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None