Penile EnhancementNCT03512717
Efficacy and Safety of Potenfill for Temporary Penile Enhancement
A study testing Potenfill and Powerfill in people with Penile Enhancement, run by Medy-Tox at 1 site in South Korea.
Trial summary
The purpose of this study is to evlauate the efficacy and safety of poteinfill, compared to the powerfill. Read more about this study
- Who is it for?
- Ages 19 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Penile Enhancement
- What is being tested?
- Potenfill and Powerfill
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Nov 2017to 31 Jul 2018
- 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 19 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male subjects aged above 19 and below 65. (20≤male≥65)
- be rating himself, when screening, as "Small or Very Small" on Self-Questioned Questionnaire ( SQQ) including the question: " How do you rate your penile size? // Very small, Small, Normal, Big, Very Big?"
- Subjects will sign an informed consent form
Who cannot join
- Prior treatment for penile enhancement (e.g. fat, dermal graft).
- Subjects who have penile malformation (e.g. Peyronie's disease), which can make impossible to perform the intervention
- Allergic to hyalluronic acid.
- Inflammatory or/and infectious disease on penis that can affect on this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Randomized, Subject-evaluator Blind, Active Controlled Design Clinical Study to Determine the Efficacy and Safety of Potenfill for Temporary Penile Enhancement
The purpose of this study is to evlauate the efficacy and safety of poteinfill, compared to the powerfill.
- Conditions
- Penile Enhancement
- Being tested
- Potenfill, Powerfill
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PotenfillDevice
Maximum: 22ml
PowerfillDevice
Maximum: 22ml
| Study group | Role | What they receive |
|---|---|---|
| Potenfill | Experimental | Not described Receives: Device: Potenfill |
| Powerfill | Active comparator | Not described Receives: Device: Powerfill |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Penile Circumference difference at 24 weeks from baseline
Penile Circumference: The average of Distal-, Mid-, and Proximal-penis measurements when relaxed by tape measurement
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2018
- Study start16 Nov 2017
- Primary completion31 Jul 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Penile EnhancementStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medy-Tox
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03512717
- Sponsor's protocol ID
- MT05-KR17PGE308
- Status last verified
- Mar 2019
- First submitted
- 27 Apr 2018
- Last updated
- 26 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Subject-evaluator Blind, Active Controlled Design Clinical Study to Determine the Efficacy and Safety of Potenfill for Temporary Penile Enhancement
- ClinicalTrials.gov ID
- NCT03512717
- Acronym / sponsor ID
- MT05-KR17PGE308
- Conditions
- Penile Enhancement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Medy-ToxIndustry (pharma, biotech, devices)
- Study start
- 16 Nov 2017 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 1 May 2018 (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.
The purpose of this study is to evlauate the efficacy and safety of poteinfill, compared to the powerfill.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Potenfill | Experimental | Device: Potenfill |
| Powerfill | Active comparator | Device: Powerfill |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male subjects aged above 19 and below 65. (20≤male≥65)
- be rating himself, when screening, as "Small or Very Small" on Self-Questioned Questionnaire ( SQQ) including the question: " How do you rate your penile size? // Very small, Small, Normal, Big, Very Big?"
- Subjects will sign an informed consent form
Key exclusion criteria (4 listed)
- Prior treatment for penile enhancement (e.g. fat, dermal graft).
- Subjects who have penile malformation (e.g. Peyronie's disease), which can make impossible to perform the intervention
- Allergic to hyalluronic acid.
- Inflammatory or/and infectious disease on penis that can affect on this study
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 |
|---|---|---|
| PotenfillMaximum: 22ml | Device | Potenfill |
| PowerfillMaximum: 22ml | Device | Powerfill |
Primary outcome
the Penile Circumference difference at 24 weeks from baseline
Time frame: 24 weeks
Penile Circumference: The average of Distal-, Mid-, and Proximal-penis measurements when relaxed by tape measurement
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 26 Mar 2019.
Related trials for Penile Enhancement
Not yet recruiting
HYAcorp MLF1 Hyaluronic Acid Filler for Penile Girth Enhancement
Penile Girth Enhancement
Not yet recruiting
Efficacy and Stability of Autologous Fat Grafting for Penile Girth Augmentation
Penile Girth Augmentation, Fat Graft
Recruiting
Fibrin-Enhanced TIP Versus Grafted TIP Urethroplasty in Distal Hypospadias
Distal Hypospadias, Hypospadias
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Potenfill and Powerfill in people with Penile Enhancement, run by Medy-Tox at 1 site in South Korea.
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 3 inclusion and 4 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 26 Mar 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 South Korea. 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?
the Penile Circumference difference at 24 weeks from baseline (time frame: 24 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 26 Mar 2019.