Efficacy and Safety of Potenfill for Temporary Penile Enhancement

Not Applicable

Completed

• Conditions: Penile Enhancement
• Interventions: Device: Potenfill; Device: Powerfill

• Registration Number: NCT03512717
• Lead Sponsor: Medy-Tox

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-16
• Study First Submitted: 2018-04-27
• Study First Submitted QC: 2018-04-27
• Study First Posted: 2018-05-01
• Primary Completion: 2018-07-31
• Study Completion: 2018-07-31
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-25
• Last Update Posted: 2019-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 76

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Potenfill	Potenfill	-
Powerfill	Powerfill	-

Primary Outcome Measures

Name	Time	Method
the Penile Circumference difference at 24 weeks from baseline	24 weeks	Penile Circumference: The average of Distal-, Mid-, and Proximal-penis measurements when relaxed by tape measurement

Trial Locations

Locations (1)

Gangdong Sacred Heart Hospital, Hallym Univ; 🇰🇷 Seoul, Korea, Republic of