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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03840070|
Recruitment Status : Completed
First Posted : February 15, 2019
Last Update Posted : July 29, 2020
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 17, 2018|
|Actual Primary Completion Date :||October 17, 2019|
|Actual Study Completion Date :||December 30, 2019|
Other Name: hyaluronic acid filler
- Subject satisfaction on the penile appearance at 12 months after application of Potenfill [ Time Frame: 12 month ]Satisfaction with the physical appearance of penis as assessed by the subject at 12 months after the application of investigational medical device.
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
|Korea, Republic of|
|Korea university guro hospital|
|Seoul, Korea, Republic of|