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

N

Nyanza Reproductive Health Society

Status

Completed

Conditions

Male Circumcision

Treatments

Device: PrePex Day 0 FRP
Device: PrePex Day 7 FRP

Study type

Interventional

Funder types

Other

Identifiers

NCT03223532
VMMC005

Details and patient eligibility

About

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

Full 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

Enrollment

152 patients

Sex

Male

Ages

13 to 49 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Ages - 13 to 49 years
  • Uncircumcised
  • Adequately vaccinated, or willing to be vaccinated, against Tetanus based on appropriate national guidance for male circumcision
  • Willing to be circumcised
  • Legal guardian consent to the procedure for ages 13-18 years
  • Agrees to be circumcised by any of the study methods, Day0 FRP or Day7 FRP as will be determined randomly
  • Able to understand the study procedures and requirements
  • Agrees to abstain from sexual intercourse for 8 weeks after circumcision
  • Agrees to abstain from masturbation for at least 2 weeks after Removal
  • Agrees to return to the health care facility for follow-up visits (or as instructed) after his circumcision for a period of 6 weeks post removal (7 weeks total)
  • Subject able to comprehend and freely give informed consent for participation in this study and is considered by the investigator to have good compliance for the study

Exclusion criteria

  • Legal guardian withholds consent for ages 13-18 years
  • Active genital infection, anatomic abnormality or other condition, which in the opinion of the investigator prevents the subject from undergoing a circumcision
  • Subject with the following diseases/conditions: phimosis, paraphimosis, adhesions, warts under the prepuce, torn or tight frenulum, narrow prepuce, hypospadias, epispadias
  • Known bleeding / coagulation abnormality, uncontrolled diabetes
  • Subject that to the opinion of the investigator is not a good candidate
  • Subject does not agree to anonymous video and photographs of the procedure and follow up visits.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

152 participants in 2 patient groups

PrePex Day 7 FRP
Active Comparator group
Description:
Standard PrePex procedure, 1 week after device placement foreskin and device are removed. \*Subjects must be adequately vaccinated, or willing to be vaccinated, against Tetanus based on appropriate national guidance for male circumcision
Treatment:
Device: PrePex Day 7 FRP
PrePex Day 0 FRP
Experimental group
Description:
On the day of device placement the foreskin is removed, the device is removed 1 week later.
Treatment:
Device: PrePex Day 0 FRP

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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