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Efficacy and Safety of 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03512717
Recruitment Status : Completed
First Posted : May 1, 2018
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Medy-Tox

Study Description
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Brief Summary:
The purpose of this study is to evlauate the efficacy and safety of poteinfill, compared to the powerfill.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : November 16, 2017
Actual Primary Completion Date : July 31, 2018
Actual Study Completion Date : July 31, 2018
Arms and Interventions
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Arm Intervention/treatment
Experimental: Potenfill Device: Potenfill
Maximum: 22ml
Active Comparator: Powerfill Device: Powerfill
Maximum: 22ml


Outcome Measures
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Primary Outcome Measures :
  1. the Penile Circumference difference at 24 weeks from baseline [ Time Frame: 24 weeks ]
    Penile Circumference: The average of Distal-, Mid-, and Proximal-penis measurements when relaxed by tape measurement


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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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): NCT03512717


Locations
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Korea, Republic of
Gangdong Sacred Heart Hospital, Hallym Univ
Seoul, Korea, Republic of
Sponsors and Collaborators
Medy-Tox
More Information
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Responsible Party: Medy-Tox
ClinicalTrials.gov Identifier: NCT03512717    
Other Study ID Numbers: MT05-KR17PGE308
First Posted: May 1, 2018    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019

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