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

Male Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00572754
• Other study ID #: Drycirc Vz10d
• Secondary ID: NEB002180
• Status: Recruiting
• Phase: Phase 2
• First received: December 12, 2007
• Last updated: December 12, 2007
• Start date: November 2007
• Est. completion date: March 2008

Study information

• Verified date: December 2007
• Source: Progressus
• Contact: Kasonde Bowa, MD
• Phone: 260 97 84 93 0
• Email: kbowa[@]yahoo.com
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: March 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years and older

Eligibility

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).

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Circumcision
• Male

Intervention

Procedure:
• Circumcision
Circumcision by tying a ligature around the foreskin.

Locations

Country	Name	City	State
Zambia	University Teaching Hospital	Lusaka

Sponsors (1)

Lead Sponsor	Collaborator
Progressus

Country where clinical trial is conducted

Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The operative and short-term post-operative safety rates		1 month	Yes
Secondary	Mobibidity and mortality The length of the residual foreskin.		1 month	Yes