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OpenTrials
Completed

NCT Number: NCT03512717

Efficacy and Safety of Potenfill for Temporary Penile Enhancement

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

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Key information

Conditions

Penile Enhancement

Age range

19 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Gangdong Sacred Heart Hospital, Hallym Univ

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male subjects aged above 19 and below 65. (20≤male≥65)
  • 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?"
  • Subjects will sign an informed consent form

Exclusion criteria

  • Prior treatment for penile enhancement (e.g. fat, dermal graft).
  • Subjects who have penile malformation (e.g. Peyronie's disease), which can make impossible to perform the intervention
  • Allergic to hyalluronic acid.
  • Inflammatory or/and infectious disease on penis that can affect on this study

Treatment and study plan

Potenfill

Device

Maximum: 22ml

Powerfill

Device

Maximum: 22ml

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Medy-Tox

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 1, 2018
Registry last updated
Mar 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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