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

NCT03223532 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2019-08-22

No results posted yet for this study

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.

Conditions

  • Male Circumcision

Interventions

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

Sponsors & Collaborators

  • Nyanza Reproductive Health Society

    lead OTHER

Principal Investigators

  • Fredrick Otieno, M.D. · Nyanza Reproductive Health Society

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
49 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-04-26
Primary Completion
2017-10-14
Completion
2017-11-15

Countries

  • Kenya

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03223532 on ClinicalTrials.gov