Efficacy and Safety of Potenfill for Temporary Penile Enhancement
A Multi-center, Randomized, Subject-evaluator Blind, Active Controlled Design Clinical Study to Determine the Efficacy and Safety of Potenfill for Temporary Penile Enhancement
1 other identifier
interventional
76
1 country
1
Brief Summary
The purpose of this study is to evlauate the efficacy and safety of poteinfill, compared to the powerfill.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 16, 2017
CompletedFirst Submitted
Initial submission to the registry
April 27, 2018
CompletedFirst Posted
Study publicly available on registry
May 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2018
CompletedMarch 26, 2019
March 1, 2019
9 months
April 27, 2018
March 25, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Potenfill
EXPERIMENTALPowerfill
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medy-Toxlead
Study Sites (1)
Gangdong Sacred Heart Hospital, Hallym Univ
Seoul, South Korea
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2018
First Posted
May 1, 2018
Study Start
November 16, 2017
Primary Completion
July 31, 2018
Study Completion
July 31, 2018
Last Updated
March 26, 2019
Record last verified: 2019-03