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

Penile Enhancement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02833532
• Other study ID #: AC-Volus-01
• Status: Completed
• Phase: Phase 3
• First received: July 12, 2016
• Last updated: August 6, 2017
• Start date: June 2015
• Est. completion date: June 2017

Study information

• Verified date: July 2016
• Source: Hugel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate non-inferial study of the after using Volus application, compared to the powerfill.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: June 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Male subjects aged above 20 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. During the study period, subjects will not received any treatments associated with penile enhancement.

4. 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

Related Conditions & MeSH terms

• Penile Enhancement

Intervention

Device:
• Volus/Powerfill
Maximum: 22ml

Locations

Country	Name	City	State
Korea, Republic of	HUGEL	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Hugel	Associacio catalana per a la recerca oncologica i les seves implicacions sanitaries i socials

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the Penile Circumference difference at 24 weeks from Baseline value after using Volus application, compared to the Control.	Penile Circumference: The average of Distal-, Mid-, and Proximal-penis measurements when relaxed by tape measurement. Baseline value: Measured baseline length before the intervention.	baseline, 24 weeks
Secondary	The Difference in Penile Circumference (each to be measured) at 4, 12 weeks (post last treatment) from Baseline value after using Volus application, compared to the Control.		baseline, 4 weeks, 12 weeks, 24 weeks
Secondary	The Difference in 5-point scale of penile appearance (each to be measured) at 4, 12, 24 weeks (post last treatment) from Baseline value after using Volus application, compared to the Control.		baseline, 4 weeks, 12 weeks, 24 weeks
Secondary	The Difference in 5-point scale of sexual satisfaction (each to be measured) at 12, 24 weeks (post last treatment)from Baseline value after using Volus application, compared to the Control.		baseline, 12 weeks, 24 weeks
Secondary	The Difference in penile length† (each to be measured) at 4, 12, 24 weeks (post last treatment) from ‡B after using Volus application, compared to the Control.	† penile length: A length of penile distribution measured from the ventral side of pubo-penile skin junction to the apex of prepuce when relaxed using a tape( or stick)- measure.	baseline, 4 weeks, 12 weeks, 24 weeks