NCT03223532

Randomized Trial Comparing PrePex Day 7 Foreskin Removal Procedure (FRP) to a Day 0 PrePex FRP .

A Prospective, Randomized, Open Label Trial Comparing PrePex™ Day 7 Foreskin Removal Procedure (FRP) to a PrePex Day 0 FRP of Male Circumcision in Resource Limited Settings

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 152 (actual)
• Sponsor: Nyanza Reproductive Health Society · Academic / Other
• Sex: Male
• Age: 13 Years – 49 Years
• Healthy volunteers: Accepted

Summary

A Prospective, Randomized, Open Label Trial Comparing PrePex™ Day 7 (FRP) to a PrePex Day 0 FRP of Male Circumcision in Resource Limited Settings.

Detailed description

Study Objectives: To compare the safety and acceptability of PrePex Day 7 Foreskin Removal Procedure (FRP) (herein: PrePex) versus PrePex Day0 FRP Planned Subjects Population: One hundred and fifty (150) subjects scheduled for voluntary medical male circumcision. The subjects will be randomly divided into two unbalanced study arms (2:1), Day0 FRP arm which will include hundred (100) subjects and PrePex arm which will include fifty (50) subjects. Study duration per subject will be up to 7 weeks and will include a total of 9 visits. Study Site: University of Nairobi, Illinois, and Manatoba (UNIM) Research and Training Centre, Kisumu, Kenya

Conditions

• Male Circumcision

Interventions

Type	Name	Description
DEVICE	PrePex Day 7 FRP	Standard PrePex procedure, foreskin and device are removed 1 week after device application.
DEVICE	PrePex Day 0 FRP	Removal of the foreskin shortly after device application, the device is removed 1 week later

Timeline

• Start date: 2017-04-26
• Primary completion: 2017-10-14
• Completion: 2017-11-15
• First posted: 2017-07-21
• Last updated: 2019-08-22

Locations

1 site across 1 country: Kenya