Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06595836
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-11
Brief Title:
Evaluation of the Performance and Acceptability of a Synthetic Polyisoprene Male Condom Compared to a Natural Rubber Latex Condom
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of the Performance and Acceptability of a Synthetic Polyisoprene Male Condom Compared to a Natural Rubber Latex Condom Phase II SlippageBreakage Study
Status:
RECRUITING
Status Verified Date:
2024-09
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 study is a masked investigators research staff two-way crossover randomized to sequence of use study designed to evaluate the acceptability and functional performance breakage slippage of a silicone lubricated polyisoprene condom and a silicone lubricated natural rubber latex condom
Detailed Description:
Three hundred 300 couples will be enrolled and asked to use five condoms of each of the two types of lubricated condoms to yield a potential sample size of 1500 uses for each type of lubricated condom To minimize a potential learning effect couples will be randomly assigned to the sequence of use of each type of lubricated condom
The primary objective of this study is to examine the slippage breakage and acceptability of a new polyisoprene male condom compared to a natural rubber latex condom The study will assess safety in terms of adverse events and user acceptability will be evaluated by comparing physical attributes of the polyisoprene and latex control condoms as well as perceptions about using the devices
The primary objective of this study is to examine the slippage breakage and acceptability of a new polyisoprene male condom compared to a natural rubber latex condom The study will assess safety in terms of adverse events and user acceptability will be evaluated by comparing physical attributes of the polyisoprene and latex control condoms as well as perceptions about using the devices
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