Phase II Trial to Evaluate the Safety and Efficacy of the Dry Circumcision Method - Full Text View

Sponsored by:	Progressus
Information provided by:	Progressus
ClinicalTrials.gov Identifier:	NCT00572754

Purpose

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.

Condition	Intervention	Phase
Circumcision Male	Procedure: Circumcision	Phase II

MedlinePlus related topics: Circumcision

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Trial to Evaluate the Safety and Efficacy of the Dry Circumcision

Further study details as provided by Progressus:

Primary Outcome Measures:

The operative and short-term post-operative safety rates [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Mobibidity and mortality The length of the residual foreskin. [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	15
Study Start Date:	November 2007
Estimated Study Completion Date:	March 2008

Intervention Details:

Circumcision by tying a ligature around the foreskin.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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.
Subjects with known diabetes, known allergy to local anaesthesia or with known abnormal blood coagulation.
Subjects whose penile circumference is higher (>3mm) or lower (<3mm) than the available circumcision tubes.
Subjects with a thick foreskin (difference between the diameter of covered glans and uncovered glans > 5mm).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00572754

Contacts

Contact: Kasonde Bowa, MD

260 97 84 93 0

kbowa@yahoo.com

Locations

Zambia
University Teaching Hospital	Recruiting
Lusaka, Zambia
Contact: Kasonde Bowa, MD
Principal Investigator: Kasonde Bowa, MD

Sponsors and Collaborators

Progressus

Investigators

Principal Investigator:

Bertran Auvert, MD, PhD

UVSQ-INSERM-France

More Information

Responsible Party:	University of Versailles (France) ( Bertran Auvert )
Study ID Numbers:	Drycirc Vz10d, NEB002180
Study First Received:	December 12, 2007
Last Updated:	December 12, 2007
ClinicalTrials.gov Identifier:	NCT00572754
Health Authority:	France: Institutional Ethical Committee

ClinicalTrials.gov processed this record on January 16, 2009