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Completed

NCT Number: 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 (FRP) to a PrePex Day 0 FRP of Male Circumcision in Resource Limited Settings.

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Key information

Conditions

Male Circumcision

Age range

13 year–49 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Nyanza Reproductive Health Society

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

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PrePex Day 7 FRP

Device

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

PrePex Day 0 FRP

Device

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

Primary outcomes

  1. Incidence of Serious Adverse Events related to the Day 0 FRP

    Time frame: 8 weeks

    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.

Secondary outcomes

  1. Acceptability of PrePex Day 0 FRP

    Time frame: 8 weeks

    Evaluating the PrePex Day 0 FRP acceptability to subjects and health care providers compared to the standard Day 7 FRP, by means of the following parameters:

    • Evaluation of pain by the following parameters: Subject's subjective pain, tingling and discomfort
    • Odour assessment while device is in situ by means of questionnaires on follow up visit 3 and on removal visit day.
    • Subjects / health care providers satisfaction

Sponsors and collaborators

Lead sponsor

Nyanza Reproductive Health Society

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jul 21, 2017
Registry last updated
Aug 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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