Penile EnhancementNCT04496427
Observational Study to Determine the Efficacy and Safety of Potenfill for Temporary Penile Enhancement
An observational study of Penile Enhancement, run by Medy-Tox at 1 site in South Korea.
Trial summary
This is an observational study to determine the efficacy and safety of Potenfill for temporary penile enhancement. The pivotal study of Potenfill has already been completed and this observational study determines the long-term efficacy and safety for up to 24 months in subjects who have been participated and treated… 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
- How many people
- 13 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Apr 2019to 11 Dec 2019
- Phase
- Observational
- 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
Study population: Males over 19 and under 65 who have participated in the previous clinical investigation (pivotal) and were treated with the investigational medical device and completed all the anticipated visits.
Who may be able to join
- Males over 19 and under 65 who have participated in the previous clinical investigation (pivotal) and were treated with the investigational medical device and completed all the anticipated visits.
Who cannot join
- Subjects who have received any procedures or surgeries (penile enhancement procedure, HA filler, collagen, etc.) in the penile area from the time after the participation of the previous clinical investigation (pivotal) and before the screening for this clinical investigation.
- Subjects deemed as ineligible to participate by the investigator
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Kangdong Sacred Heart Hospital
Seoul, Gangdong-gu, 05355
About this study
Official title: A Single-center, Long-term, Observational Study to Determine the Efficacy and Safety of Potenfill for Temporary Penile Enhancement
This is an observational study to determine the efficacy and safety of Potenfill for temporary penile enhancement.
The pivotal study of Potenfill has already been completed and this observational study determines the long-term efficacy and safety for up to 24 months in subjects who have been participated and treated in the pivotal study.
- Conditions
- Penile Enhancement
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction with the appearance of penis assessed by the Subject Satisfaction at 18 months after treatment with Potenfill compared to baseline
Satisfaction with the physical appearance of the penis as assessed by the subject at 18 months after application of the investigational medical device compared to baseline. The Subject Satisfaction score ranges from 1 (extremely unsatisfied) to 7 (extremely satisfied).
Measured: 18 months
Satisfaction with the appearance of penis assessed by the Subject Satisfaction at 24 months after treatment with Potenfill compared to baseline
Satisfaction with the physical appearance of the penis as assessed by the subject at 24 months after application of the investigational medical device compared to baseline. The Subject Satisfaction score ranges from 1 (extremely unsatisfied) to 7 (extremely satisfied).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2020
- Study start10 Apr 2019
- Primary completion15 Nov 2019
- Study completion11 Dec 2019
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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 13 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
- NCT04496427
- Sponsor's protocol ID
- MT05-KR19PGE1101
- Status last verified
- Jul 2020
- First submitted
- 27 Jul 2020
- Last updated
- 3 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Long-term, Observational Study to Determine the Efficacy and Safety of Potenfill for Temporary Penile Enhancement
- ClinicalTrials.gov ID
- NCT04496427
- Acronym / sponsor ID
- MT05-KR19PGE1101
- Conditions
- Penile Enhancement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Medy-ToxIndustry (pharma, biotech, devices)
- Study start
- 10 Apr 2019 (actual)
- Primary completion
- 15 Nov 2019 (actual)
- Study completion
- 11 Dec 2019 (actual)
- First posted
- 3 Aug 2020 (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 is an observational study to determine the efficacy and safety of Potenfill for temporary penile enhancement.
The pivotal study of Potenfill has already been completed and this observational study determines the long-term efficacy and safety for up to 24 months in subjects who have been participated and treated in the pivotal study.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Males over 19 and under 65 who have participated in the previous clinical investigation (pivotal) and were treated with the investigational medical device and completed all the anticipated visits.
Key inclusion criteria (1 listed)
- Males over 19 and under 65 who have participated in the previous clinical investigation (pivotal) and were treated with the investigational medical device and completed all the anticipated visits.
Key exclusion criteria (2 listed)
- Subjects who have received any procedures or surgeries (penile enhancement procedure, HA filler, collagen, etc.) in the penile area from the time after the participation of the previous clinical investigation (pivotal) and before the screening for this clinical investigation.
- Subjects deemed as ineligible to participate by the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Satisfaction with the appearance of penis assessed by the Subject Satisfaction at 18 months after treatment with Potenfill compared to baseline
Time frame: 18 months
Satisfaction with the physical appearance of the penis as assessed by the subject at 18 months after application of the investigational medical device compared to baseline. The Subject Satisfaction score ranges from 1 (extremely unsatisfied) to 7 (extremely satisfied).
Satisfaction with the appearance of penis assessed by the Subject Satisfaction at 24 months after treatment with Potenfill compared to baseline
Time frame: 24 months
Satisfaction with the physical appearance of the penis as assessed by the subject at 24 months after application of the investigational medical device compared to baseline. The Subject Satisfaction score ranges from 1 (extremely unsatisfied) to 7 (extremely satisfied).
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 3 Aug 2020.
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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?
An observational study of 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 1 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 3 Aug 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?
Satisfaction with the appearance of penis assessed by the Subject Satisfaction at 18 months after treatment with Potenfill compared to baseline (time frame: 18 months). The study lists 2 primary outcomes in all. 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 3 Aug 2020.