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

Male Circumcision Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03223532
• Other study ID #: VMMC005
• Status: Completed
• Phase: N/A
• Start date: April 26, 2017
• Est. completion date: November 15, 2017

Study information

• Verified date: August 2019
• Source: Nyanza Reproductive Health Society
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: November 15, 2017
• Est. primary completion date: October 14, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 13 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• Male Circumcision

Intervention

Device:
• PrePex Day 7 FRP
Standard PrePex procedure, foreskin and device are removed 1 week after device application.
• PrePex Day 0 FRP
Removal of the foreskin shortly after device application, the device is removed 1 week later

Locations

Country	Name	City	State
Kenya	Nyanza Reproductive Health Society	Kisumu	Nyanza

Sponsors (1)

Lead Sponsor	Collaborator
Nyanza Reproductive Health Society

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Acceptability of PrePex Day 0 FRP	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	8 weeks