Shafer Width and Girth: The Use of Injectable Fillers for Penile Enhancement

Micropenis Clinical Trial

Official title:

Shafer Width and Girth: The Use of Injectable Fillers for Penile Enhancement

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04755634
• Other study ID #: Pro00034295
• Status: Recruiting
• Phase: N/A
• Start date: April 23, 2021
• Est. completion date: December 2023

Study information

• Verified date: August 2022
• Source: Shafer Clinic Fifth Avenue
• Contact: Director Clinical Studies
• Phone: 12012802127
• Email: mussarrathussain[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Injectable filler will be performed by Principal Investigator under sterile conditions for the enhancement of girth and surface area of the penis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy males,

• 21 to 65 years of age,

• Seeking enhancement of their penile width and girth.

Exclusion Criteria:

• Patient with a history of psychological or psychiatric illness,

• Congenital or acquired penile malformation,

• Previous plastic surgery or non-invasive treatments of their penis,

• Any chronic disease such as vascular disorder, urological disorder, myocardial infarction, hypertension, cerebrovascular accident or coagulopathy.

• Patients with a history of allergic reactions to hyaluronic acid derivatives

• Individuals with penises measured less than 6 cm in length in the flaccid position

• Individuals with penises greater than 12.5 cm in length in the flaccid position.

• Individuals with uncircumcised penises

Related Conditions & MeSH terms

• Micropenis

Intervention

Device:
• Hyaluronic Acid
Injectable

Locations

Country	Name	City	State
United States	Shafer Clinic Fifth Avenue	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Shafer Clinic Fifth Avenue

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in penile width and girth	Three-dimensional (3D) surface images taken by a digital stereophotogrammetry system at the baseline will be compared to the images taken at 1 year post-treatment follow up.	1 year
Secondary	Duration of increase in penile width and girth	For how long duration the treatment will produce a measurable difference in penile size.	1 year