CircumcisionPhase 2NCT00572754
Phase II Trial to Evaluate the Safety and Efficacy of the Dry Circumcision Method
A Phase 2 study testing Circumcision in people with Circumcision and Male, run by Progressus at 1 site in Zambia.
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. Read more about this study
- Who is it for?
- Ages 21 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Circumcision, Male
- What is being tested?
- Circumcision
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteZambia
- Study dates
- Nov 2007to Mar 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
Zambia1 site, 1 recruiting
- Recruiting
University Teaching Hospital
Lusaka
Kasonde Bowa, MD
Kasonde Bowa, MD
About this study
Official title: 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.
- Conditions
- Circumcision, Male
- Being tested
- Circumcision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CircumcisionProcedure or surgery
Circumcision by tying a ligature around the foreskin.
What is being measured
The primary outcome is the main question the study is designed to answer.
The operative and short-term post-operative safety rates
Measured: 1 month
Secondary outcomes (1)
Mobibidity and mortality The length of the residual foreskin.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2007 (estimated)
- Study startNov 2007
- Study completionMar 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CircumcisionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Progressus
- Sponsor type
- University, hospital or other
- Investigators
- Bertran Auvert, MD, PhD, Principal investigator, UVSQ-INSERM-France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00572754
- Sponsor's protocol ID
- Drycirc Vz10d
- Other IDs
- NEB002180
- Status last verified
- Dec 2007
- First submitted
- 12 Dec 2007
- Last updated
- 13 Dec 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial to Evaluate the Safety and Efficacy of the Dry Circumcision
- ClinicalTrials.gov ID
- NCT00572754
- Acronym / sponsor ID
- Drycirc Vz10d
- Conditions
- Circumcision, Male
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- ProgressusUniversity, hospital or other
- Study start
- Nov 2007
- Study completion
- Mar 2008 (estimated)
- First posted
- 13 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CircumcisionCircumcision by tying a ligature around the foreskin. | Procedure or surgery | – |
Primary outcome
The operative and short-term post-operative safety rates
Time frame: 1 month
1 secondary outcome
Mobibidity and mortality The length of the residual foreskin.
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bertran Auvert, MD, PhD principal investigator
UVSQ-INSERM-France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Circumcision in people with Circumcision and Male, run by Progressus at 1 site in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kasonde Bowa, MD (260 97 84 93 0, kbowa@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The operative and short-term post-operative safety rates (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2007; AzTrials last refreshed its copy on 7 Nov 2026.