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NCT03840070 Clinical Trial

The Efficacy and Safety of Repeat-dose Potenfill for Temporary Penile Enhancement

Penile Enhancement Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03840070
Other study ID # MT05-KR18PGE1005
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 17, 2018
Est. completion date December 30, 2019

Study information
Verified date July 2020
Source Medy-Tox
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date December 30, 2019
Est. primary completion date October 17, 2019
Accepts healthy volunteers No
Gender Male
Age group 19 Years to 65 Years
Eligibility Inclusion Criteria:

- Male subjects aged above 19 and below 65. (20=male=65)

- Subjects will sign an informed consent form

Exclusion Criteria:

- Prior treatment for penile enhancement (e.g. fat, dermal graft).

- Allergic to hyalluronic acid.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Potenfill
Maximum: 22ml

Locations
Country Name City State
Korea, Republic of Korea university guro hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Medy-Tox

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 12 month
See also
  Status Clinical Trial Phase
Completed NCT03512717 - Efficacy and Safety of Potenfill for Temporary Penile Enhancement N/A
Completed NCT02833532 - A Multi-center, Randomized, Subject Blind, Active Controlled Design Clinical Study to Evaluate the Efficacy and Safety of Volus as Compared to PowerFill® for Temporary Penile Enhancement Phase 3
Completed NCT03153735 - Clinical Study to CMDHA0101 as Compared to PowerFill® for Temporary Penile Enhancement N/A
Completed NCT04496427 - Observational Study to Determine the Efficacy and Safety of Potenfill for Temporary Penile Enhancement