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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03840070
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Medy-Tox

Brief 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.


Condition or disease Intervention/treatment Phase
Penile Girth Enhancement Penile Enhancement Device: Potenfill Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 24, 2018
Estimated Primary Completion Date : March 24, 2020
Estimated Study Completion Date : March 24, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Potenfill Device: Potenfill
Maximum: 22ml
Other Name: hyaluronic acid filler




Primary Outcome Measures :
  1. the satisfaction score [ Time Frame: 12 month ]
    7 scale



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03840070


Locations
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Korea, Republic of
Korea university guro hospital Recruiting
Seoul, Korea, Republic of
Contact: Du geon Moon    82-2-2626-3201    damoon@korea.ac.kr   
Principal Investigator: Du geon Moon         
Sponsors and Collaborators
Medy-Tox

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Responsible Party: Medy-Tox
ClinicalTrials.gov Identifier: NCT03840070     History of Changes
Other Study ID Numbers: MT05-KR18PGE1005
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents