NCT03223532

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 26, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 21, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 14, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2017

Completed
Last Updated

August 22, 2019

Status Verified

August 1, 2019

Enrollment Period

6 months

First QC Date

July 18, 2017

Last Update Submit

August 20, 2019

Conditions

Male Circumcision

Outcome Measures

Primary Outcomes (1)

  • Incidence of Serious Adverse Events related to the Day 0 FRP

    Assessing the safety of PrePex Day 0 FRP compared to the standard Day 7 FRP, by means of the following parameter: Incidence of Serious Adverse Events.

    8 weeks

Secondary Outcomes (1)

  • Acceptability of PrePex Day 0 FRP

    8 weeks

Study Arms (2)

PrePex Day 7 FRP

ACTIVE COMPARATOR

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

Device: PrePex Day 7 FRP

PrePex Day 0 FRP

EXPERIMENTAL

On the day of device placement the foreskin is removed, the device is removed 1 week later.

Device: PrePex Day 0 FRP

Interventions

PrePex Day 7 FRPDEVICE

Standard PrePex procedure, foreskin and device are removed 1 week after device application.

PrePex Day 7 FRP
PrePex Day 0 FRPDEVICE

Removal of the foreskin shortly after device application, the device is removed 1 week later

PrePex Day 0 FRP

Eligibility Criteria

Age13 Years - 49 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsUncircumcised males willing to undergo the non-surgical PrePex male circumcision procedure
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nyanza Reproductive Health Society

Kisumu, Nyanza, P.O. Box 1764, Kenya

Location

Study Officials

  • Fredrick Otieno, M.D.

    Nyanza Reproductive Health Society

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A Prospective, Randomized, Open Label Trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2017

First Posted

July 21, 2017

Study Start

April 26, 2017

Primary Completion

October 14, 2017

Study Completion

November 15, 2017

Last Updated

August 22, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

KE(1)