Male CircumcisionNCT03223532
Randomized Trial Comparing PrePex Day 7 Foreskin Removal Procedure (FRP) to a Day 0 PrePex FRP .
A study testing PrePex Day 7 FRP and PrePex Day 0 FRP in people with Male Circumcision, run by Nyanza Reproductive Health Society at 1 site in Kenya.
Trial summary
A Prospective, Randomized, Open Label Trial Comparing PrePex™ Day 7 (FRP) to a PrePex Day 0 FRP of Male Circumcision in Resource Limited Settings. Read more about this study
- Who is it for?
- Ages 13 to 49 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Male Circumcision
- What is being tested?
- PrePex Day 7 FRP and PrePex Day 0 FRP
- Type of treatment
- Vaccines, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteKenya
- Study dates
- 26 Apr 2017to 15 Nov 2017
- Phase
- Interventional
- 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 13 to 49 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Ages - 13 to 49 years
- Uncircumcised
- Adequately vaccinated, or willing to be vaccinated, against Tetanus based on appropriate national guidance for male circumcision
- Willing to be circumcised
- Legal guardian consent to the procedure for ages 13-18 years
- Agrees to be circumcised by any of the study methods, Day0 FRP or Day7 FRP as will be determined randomly
Show all 11Show fewer
- Able to understand the study procedures and requirements
- Agrees to abstain from sexual intercourse for 8 weeks after circumcision
- Agrees to abstain from masturbation for at least 2 weeks after Removal
- Agrees to return to the health care facility for follow-up visits (or as instructed) after his circumcision for a period of 6 weeks post removal (7 weeks total)
- Subject able to comprehend and freely give informed consent for participation in this study and is considered by the investigator to have good compliance for the study
Who cannot join
- Legal guardian withholds consent for ages 13-18 years
- Active genital infection, anatomic abnormality or other condition, which in the opinion of the investigator prevents the subject from undergoing a circumcision
- Subject with the following diseases/conditions: phimosis, paraphimosis, adhesions, warts under the prepuce, torn or tight frenulum, narrow prepuce, hypospadias, epispadias
- Known bleeding / coagulation abnormality, uncontrolled diabetes
- Subject that to the opinion of the investigator is not a good candidate
- Subject does not agree to anonymous video and photographs of the procedure and follow up visits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Open Label Trial Comparing PrePex™ Day 7 Foreskin Removal Procedure (FRP) to a PrePex Day 0 FRP of Male Circumcision in Resource Limited Settings
A Prospective, Randomized, Open Label Trial Comparing PrePex™ Day 7 (FRP) to a PrePex Day 0 FRP of Male Circumcision in Resource Limited Settings.
Read the detailed description
Study Objectives:
To compare the safety and acceptability of PrePex Day 7 Foreskin Removal Procedure (FRP) (herein: PrePex) versus PrePex Day0 FRP
Planned Subjects Population:
One hundred and fifty (150) subjects scheduled for voluntary medical male circumcision. The subjects will be randomly divided into two unbalanced study arms (2:1), Day0 FRP arm which will include hundred (100) subjects and PrePex arm which will include fifty (50) subjects.
Study duration per subject will be up to 7 weeks and will include a total of 9 visits.
Study Site: University of Nairobi, Illinois, and Manatoba (UNIM) Research and Training Centre, Kisumu, Kenya
- Conditions
- Male Circumcision
- Being tested
- PrePex Day 7 FRP, PrePex Day 0 FRP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrePex Day 7 FRPDevice
Standard PrePex procedure, foreskin and device are removed 1 week after device application.
PrePex Day 0 FRPDevice
Removal of the foreskin shortly after device application, the device is removed 1 week later
| Study group | Role | What they receive |
|---|---|---|
| PrePex Day 7 FRP | Active comparator | Standard PrePex procedure, 1 week after device placement foreskin and device are removed.
*Subjects must be adequately vaccinated, or willing to be vaccinated, against Tetanus based on appropriate national guidance for male circumcision Receives: Device: PrePex Day 7 FRP |
| PrePex Day 0 FRP | Experimental | On the day of device placement the foreskin is removed, the device is removed 1 week later. Receives: Device: PrePex Day 0 FRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Serious Adverse Events related to the Day 0 FRP
Assessing the safety of PrePex Day 0 FRP compared to the standard Day 7 FRP, by means of the following parameter: Incidence of Serious Adverse Events.
Measured: 8 weeks
Secondary outcomes (1)
Acceptability of PrePex Day 0 FRP
Evaluating the PrePex Day 0 FRP acceptability to subjects and health care providers compared to the standard Day 7 FRP, by means of the following parameters:
- Evaluation of pain by the following parameters: Subject's subjective pain, tingling and discomfort
- Odour assessment while device is in situ by means of questionnaires on follow up visit 3 and on removal visit day.
- Subjects / health care providers satisfaction
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start26 Apr 2017
- Primary completion14 Oct 2017
- Study completion15 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Prospective, Randomized, Open Label Trial.
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nyanza Reproductive Health Society
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fredrick Otieno, M.D., Principal investigator, Nyanza Reproductive Health Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03223532
- Sponsor's protocol ID
- VMMC005
- Status last verified
- Aug 2019
- First submitted
- 18 Jul 2017
- Last updated
- 22 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Open Label Trial Comparing PrePex™ Day 7 Foreskin Removal Procedure (FRP) to a PrePex Day 0 FRP of Male Circumcision in Resource Limited Settings
- ClinicalTrials.gov ID
- NCT03223532
- Acronym / sponsor ID
- VMMC005
- Conditions
- Male Circumcision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Nyanza Reproductive Health SocietyUniversity, hospital or other
- Study start
- 26 Apr 2017 (actual)
- Primary completion
- 14 Oct 2017 (actual)
- Study completion
- 15 Nov 2017 (actual)
- First posted
- 21 Jul 2017 (actual)
- 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.
A Prospective, Randomized, Open Label Trial Comparing PrePex™ Day 7 (FRP) to a PrePex Day 0 FRP of Male Circumcision in Resource Limited Settings.
Detailed description
Study Objectives:
To compare the safety and acceptability of PrePex Day 7 Foreskin Removal Procedure (FRP) (herein: PrePex) versus PrePex Day0 FRP
Planned Subjects Population:
One hundred and fifty (150) subjects scheduled for voluntary medical male circumcision. The subjects will be randomly divided into two unbalanced study arms (2:1), Day0 FRP arm which will include hundred (100) subjects and PrePex arm which will include fifty (50) subjects.
Study duration per subject will be up to 7 weeks and will include a total of 9 visits.
Study Site: University of Nairobi, Illinois, and Manatoba (UNIM) Research and Training Centre, Kisumu, Kenya
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A Prospective, Randomized, Open Label Trial.
| Arm | Type | Receives |
|---|---|---|
| PrePex Day 7 FRP | Active comparator | Device: PrePex Day 7 FRPStandard PrePex procedure, 1 week after device placement foreskin and device are removed. *Subjects must be adequately vaccinated, or willing to be vaccinated, against Tetanus based on appropriate national guidance for male circumcision |
| PrePex Day 0 FRP | Experimental | Device: PrePex Day 0 FRPOn the day of device placement the foreskin is removed, the device is removed 1 week later. |
Who may qualify
- Ages
- 13 to 49 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Ages - 13 to 49 years
- Uncircumcised
- Adequately vaccinated, or willing to be vaccinated, against Tetanus based on appropriate national guidance for male circumcision
- Willing to be circumcised
- Legal guardian consent to the procedure for ages 13-18 years
Key exclusion criteria (6 listed)
- Legal guardian withholds consent for ages 13-18 years
- Active genital infection, anatomic abnormality or other condition, which in the opinion of the investigator prevents the subject from undergoing a circumcision
- Subject with the following diseases/conditions: phimosis, paraphimosis, adhesions, warts under the prepuce, torn or tight frenulum, narrow prepuce, hypospadias, epispadias
- Known bleeding / coagulation abnormality, uncontrolled diabetes
- Subject that to the opinion of the investigator is not a good candidate
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 |
|---|---|---|
| PrePex Day 7 FRPStandard PrePex procedure, foreskin and device are removed 1 week after device application. | Device | PrePex Day 7 FRP |
| PrePex Day 0 FRPRemoval of the foreskin shortly after device application, the device is removed 1 week later | Device | PrePex Day 0 FRP |
Primary outcome
Incidence of Serious Adverse Events related to the Day 0 FRP
Time frame: 8 weeks
Assessing the safety of PrePex Day 0 FRP compared to the standard Day 7 FRP, by means of the following parameter: Incidence of Serious Adverse Events.
1 secondary outcome
Acceptability of PrePex Day 0 FRP
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2019.
- Individual participant dataSharing planned: No
Related trials for Male Circumcision
Not yet recruitingObservational study
Preoperative Fasting and Perioperative Outcomes in Children Undergoing Elective Circumcision
Preoperative Fasting, Perioperative Anxiety
Active, not recruiting
A Study Comparing The Effect Of Local Application Of Polyfax Versus Coconut Oil On Outcome Of Plastibell Circumcision In A Tertiary Care Hospital
Circumcision, Male
Not yet recruiting
Effects of Therapeutic Touch and Music on Children's Anxiety, Pain, and Nausea Before and After Circumcision
Circumcision
Not yet recruitingPhase 2
Efficacy and Safety of Circumcision Alone on Risk of Febrile Urinary Tract Infections in Boys With Posterior Urethral Valves: a Prospective Randomized Open-label Multicentric Trial Enriched With Historic Controls.
Posterior Urethral Valves
Recruiting
Compared Reversed US-Guided Dorsal Penile Nerve Block (RUSDPNB) With DPNB in Circumcisions for Pediatric Patients
Circumcision, Ultrasound
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.
Fredrick Otieno, M.D. principal investigator
Nyanza Reproductive Health Society
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PrePex Day 7 FRP and PrePex Day 0 FRP in people with Male Circumcision, run by Nyanza Reproductive Health Society at 1 site in Kenya.
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 11 inclusion and 6 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: finished, as of the sponsor's last update on 22 Aug 2019. 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 Kenya. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Serious Adverse Events related to the Day 0 FRP (time frame: 8 weeks). 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 22 Aug 2019.