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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00572754
Recruitment Status : Unknown
Verified December 2007 by Progressus.
Recruitment status was:  Recruiting
First Posted : December 13, 2007
Last Update Posted : December 13, 2007
Information provided by:

December 12, 2007
December 13, 2007
December 13, 2007
November 2007
Not Provided
The operative and short-term post-operative safety rates [ Time Frame: 1 month ]
Same as current
No Changes Posted
Mobibidity and mortality The length of the residual foreskin. [ Time Frame: 1 month ]
Same as current
Not Provided
Not Provided
Phase II Trial to Evaluate the Safety and Efficacy of the Dry Circumcision Method
Phase II Trial to Evaluate the Safety and Efficacy of the Dry Circumcision
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.
Not Provided
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Circumcision
  • Male
Procedure: Circumcision
Circumcision by tying a ligature around the foreskin.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
March 2008
Not Provided

Inclusion Criteria:

  1. Male subjects, aged 21 years or above at the point of screening for participation.
  2. Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
  3. 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.
  4. Subjects willing to be circumcised for cultural reasons.
  5. Subjects living in the site's area.
  6. Subjects who can be easily contacted by telephone.
  7. Subjects who can correctly speak and correctly read English.

Exclusion Criteria:

  1. Subjects who, in the opinion of the investigator, have an existing condition that would compromise their participation and follow-up in this study.
  2. Subjects who are circumcised (i.e. subjects with a foreskin unable to cover the entire glans without pulling on the foreskin).
  3. Subjects with a disease which is an indication for circumcision: phimosis, paraphimosis, warts under the prepuce, torn or tight frenulum.
  4. Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
  5. Subjects who have participated in a clinical study with an investigational product in the last 6 months.
  6. Subjects who have an abnormal penile anatomy.
  7. Subjects who are currently involved in any injury litigation claims.
  8. Subjects who have penile diseases or lesions.
  9. Subjects who have clinical symptoms of sexually transmitted infections.
  10. Subjects with opportunistic infections.
  11. Subjects with known diabetes, known allergy to local anaesthesia or with known abnormal blood coagulation.
  12. Subjects whose penile circumference is higher (>3mm) or lower (<3mm) than the available circumcision tubes.
  13. Subjects with a thick foreskin (difference between the diameter of covered glans and uncovered glans > 5mm).
Sexes Eligible for Study: Male
21 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Drycirc Vz10d
Not Provided
Not Provided
Bertran Auvert, University of Versailles (France)
Not Provided
Principal Investigator: Bertran Auvert, MD, PhD UVSQ-INSERM-France
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP