Penile Girth EnhancementNCT03840070
The Efficacy and Safety of Repeat-dose Potenfill for Temporary Penile Enhancement
A study testing Potenfill in people with Penile Girth Enhancement and Penile Enhancement, run by Medy-Tox at 1 site in South Korea.
Trial summary
This clinical study is for small-penis syndrome males who have previously been treated with hyaluronic acid filler for the purpose of increasing their penis. This study will determine the long-term efficacy and safety of Potenfill. Read more about this study
- Who is it for?
- Ages 19 to 65 years, men only
- Conditions the study is for
- Penile Girth Enhancement, Penile Enhancement
- What is being tested?
- Potenfill
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Dec 2018to 30 Dec 2019
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male subjects aged above 19 and below 65. (20≤male≥65)
- Subjects will sign an informed consent form
Who cannot join
- Prior treatment for penile enhancement (e.g. fat, dermal graft).
- Allergic to hyalluronic acid.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Open-label, Long-term, Exploratory Study to Determine the Efficacy and Safety of Repeat-dose Potenfill for Temporary Penile Enhancement
This clinical study is for small-penis syndrome males who have previously been treated with hyaluronic acid filler for the purpose of increasing their penis.
This study will determine the long-term efficacy and safety of Potenfill.
- Conditions
- Penile Girth Enhancement, Penile Enhancement
- Being tested
- Potenfill
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PotenfillDevice
Also called hyaluronic acid filler
Maximum: 22ml
| Study group | Role | What they receive |
|---|---|---|
| Potenfill | Experimental | Not described Receives: Device: Potenfill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject satisfaction on the penile appearance at 12 months after application of Potenfill
Satisfaction with the physical appearance of penis as assessed by the subject at 12 months after the application of investigational medical device.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start17 Dec 2018
- Primary completion17 Oct 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Penile Girth 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT03840070
- Sponsor's protocol ID
- MT05-KR18PGE1005
- Status last verified
- Jul 2020
- First submitted
- 7 Feb 2019
- Last updated
- 29 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open-label, Long-term, Exploratory Study to Determine the Efficacy and Safety of Repeat-dose Potenfill for Temporary Penile Enhancement
- ClinicalTrials.gov ID
- NCT03840070
- Acronym / sponsor ID
- MT05-KR18PGE1005
- Conditions
- Penile Girth Enhancement, Penile Enhancement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Medy-ToxIndustry (pharma, biotech, devices)
- Study start
- 17 Dec 2018 (actual)
- Primary completion
- 17 Oct 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 15 Feb 2019 (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.
This clinical study is for small-penis syndrome males who have previously been treated with hyaluronic acid filler for the purpose of increasing their penis.
This study will determine the long-term efficacy and safety of Potenfill.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Potenfill | Experimental | Device: Potenfill |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male subjects aged above 19 and below 65. (20≤male≥65)
- Subjects will sign an informed consent form
Key exclusion criteria (2 listed)
- Prior treatment for penile enhancement (e.g. fat, dermal graft).
- Allergic to hyalluronic acid.
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 |
|---|---|---|
| PotenfillAlso: hyaluronic acid fillerMaximum: 22ml | Device | Potenfill |
Primary outcome
Subject satisfaction on the penile appearance at 12 months after application of Potenfill
Time frame: 12 month
Satisfaction with the physical appearance of penis as assessed by the subject at 12 months after the application of investigational medical device.
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 29 Jul 2020.
- Individual participant dataSharing planned: Undecided
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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.
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 in people with Penile Girth Enhancement and 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 2 inclusion and 2 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 29 Jul 2020. 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?
Subject satisfaction on the penile appearance at 12 months after application of Potenfill (time frame: 12 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 29 Jul 2020.