Efficacy and Safety of Potenfill for Temporary Penile Enhancement

Penile Enhancement Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03512717
• Other study ID #: MT05-KR17PGE308
• Status: Completed
• Phase: N/A
• Start date: November 16, 2017
• Est. completion date: July 31, 2018

Study information

• Verified date: March 2019
• Source: Medy-Tox
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evlauate the efficacy and safety of poteinfill, compared to the powerfill.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: July 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 65 Years

Eligibility

Inclusion Criteria:

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

2. 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?"

3. Subjects will sign an informed consent form

Exclusion Criteria:

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

2. Subjects who have penile malformation (e.g. Peyronie's disease), which can make impossible to perform the intervention

3. Allergic to hyalluronic acid.

4. Inflammatory or/and infectious disease on penis that can affect on this study

Related Conditions & MeSH terms

• Penile Enhancement

Intervention

Device:
• Potenfill
Maximum: 22ml
• Powerfill
Maximum: 22ml

Locations

Country	Name	City	State
Korea, Republic of	Gangdong Sacred Heart Hospital, Hallym Univ	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	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	24 weeks