NCT03153735

Clinical Study to CMDHA0101 as Compared to PowerFill® for Temporary Penile Enhancement

A Multi-center, Randomized, Subject Blind, Active Controlled Design Clinical Study to Evaluate the Efficacy and Safety of CMDHA0101 as Compared to PowerFill® for Temporary Penile Enhancement

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: CHA MEDITECH Co., Ltd. · Industry
• Sex: Male
• Age: 20 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The investigators aimed to confirm the efficacy and safety of transdermal penis enlargement for 24 weeks after CMDHA0101 injection in subjects who wanted penile enlargement in male patients with small-penis syndrome \*. \*Small-penis syndrome is the anxiety of thinking one's penis is too small - even though it isn't.

Detailed description

This study was designed as a 24-week, randomized, blinded, active control trial. If a subject signing a clinical trial agreement and satisfying the selection / exclusion criteria is enrolled in this clinical trial, he / she will receive the medical device for clinical testing at the baseline time, return to his / her home after the training . At 4 weeks, 12 weeks, and 24 weeks after the application of the medical device for clinical testing at baseline, the safety, penile girth, length, and satisfaction of the subject were evaluated. 24 weeks after application, the clinical trial sponsor (or trustee) retrieves the data necessary for the analysis of results, such as case records, for the purpose of validity and safety evaluation

Conditions

• Small Penis
• Penile Enhancement

Interventions

Type	Name	Description
DEVICE	CMDHA0101	Maximum injection dose : 22 ml
DEVICE	PowerFill®	Maximum injection dose : 22 ml

Timeline

• Start date: 2016-12-02
• Primary completion: 2017-11-07
• Completion: 2017-11-07
• First posted: 2017-05-15
• Last updated: 2017-12-12

Locations

1 site across 1 country: South Korea