Ignite Creation Date:
2024-05-06 @ 1:49 PM
Last Modification Date:
2024-10-26 @ 1:20 PM
Study NCT ID:
NCT04134039
Status:
COMPLETED
Last Update Posted:
2021-09-16
First Post:
2019-10-11
Brief Title:
A Clinical Investigation to Assess the Performance of a Polyurethane Condom Versus a Latex Condom in Healthy Monogamous Couples
Sponsor:
Reckitt Benckiser Healthcare UK Limited
Organization:
Reckitt Benckiser Healthcare UK Limited
Study Overview
Official Title:
A Randomized Assessor-masked 2-way Cross-over Multi-centre Clinical Investigation to Evaluate the Performance Rate of a Polyurethane Condom in Healthy Monogamous Couples When Compared With a Standard Latex Condom
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
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 a polyurethane PU condom versus a standard natural rubber latex NRL condom
Detailed Description:
In this clinical investigation a new PU male condom test condom will be evaluated against a marketed NRL male condom reference condom This clinical investigation will also evaluate the in-use tolerance of the test and reference condoms
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None