Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-28 @ 9:06 PM
Study NCT ID:
NCT06079060
Status:
COMPLETED
Last Update Posted:
2025-10-24
First Post:
2023-09-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Synthetic Nitrile Male Condom Compared to Standard Latex Male Condom
Sponsor:
Karex Industries Sdn. Bhd.
Organization:
Study Overview
Official Title:
A Functional Performance and Acceptability Evaluation of Synthetic Nitrile Male Condom Compared to a Standard Latex Male Condom
Status:
COMPLETED
Status Verified Date:
2025-10
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:
Thia is a multi-site, randomised 2-period cross-over trial comparing five uses of a 61 mm width synthetic nitrile male condom with five uses of a 61 mm width standard latex male condom.
Detailed Description:
A sequential randomised 2-period cross-over trial comparing five uses of a 61 mm width synthetic nitrile male condom with five uses of a 61 mm width standard latex male condom. Each couple will be asked to use five synthetic nitrile condoms, and five latex control male condoms in a randomised order. Couples will complete a Condom Use Report after each condom use. Function, safety, and acceptability will be assessed at each of two follow-up visits conducted after using each set of five condoms. The trial will enrol up to 300 couples, anticipating that at least 255 couples will complete the study. Half of the couples (150) will be enrolled in Durban, South Africa and half (150) enrolled in California USA.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: