Phase II Trial to Evaluate the Safety and Efficacy of the Dry Circumcision

Progressus1 site in 1 country15 target enrollmentNovember 2007

ConditionsCircumcision Male

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Circumcision
Sponsor: Progressus
Enrollment: 15
Locations: 1
Primary Endpoint: The operative and short-term post-operative safety rates
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this clinical investigation is to provide the first and preliminary clinical data to study the safety and efficacy of male circumcision where the dry circumcision method is employed.

Registry

clinicaltrials.gov

Start Date

November 2007

End Date

March 2008

Last Updated

18 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Progressus

Eligibility Criteria

Inclusion Criteria

•Male subjects, aged 21 years or above at the point of screening for participation.
•Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
•Subjects who, in the opinion of the clinical investigator, are able to understand this clinical investigation co-operate with the investigational procedures and are willing to return to the clinical centre for all the required post-treatment follow-ups.
•Subjects willing to be circumcised for cultural reasons.
•Subjects living in the site's area.
•Subjects who can be easily contacted by telephone.
•Subjects who can correctly speak and correctly read English.

Exclusion Criteria

•Subjects who, in the opinion of the investigator, have an existing condition that would compromise their participation and follow-up in this study.
•Subjects who are circumcised (i.e. subjects with a foreskin unable to cover the entire glans without pulling on the foreskin).
•Subjects with a disease which is an indication for circumcision: phimosis, paraphimosis, warts under the prepuce, torn or tight frenulum.
•Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
•Subjects who have participated in a clinical study with an investigational product in the last 6 months.
•Subjects who have an abnormal penile anatomy.
•Subjects who are currently involved in any injury litigation claims.
•Subjects who have penile diseases or lesions.
•Subjects who have clinical symptoms of sexually transmitted infections.
•Subjects with opportunistic infections.