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

August 6, 2017 updated by: Hugel
The purpose of this study is to evaluate non-inferial study of the after using Volus application, compared to the powerfill.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

68

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Volus
Maxium: 22ml
Device: Volus/Powerfill
Maximum: 22ml
Active Comparator: Powerfill
Maxium: 22ml
Device: Volus/Powerfill
Maximum: 22ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the Penile Circumference difference at 24 weeks from Baseline value after using Volus application, compared to the Control.
Time Frame: baseline, 24 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: baseline, 4 weeks, 12 weeks, 24 weeks
baseline, 4 weeks, 12 weeks, 24 weeks
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.
Time Frame: baseline, 4 weeks, 12 weeks, 24 weeks
baseline, 4 weeks, 12 weeks, 24 weeks
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.
Time Frame: baseline, 12 weeks, 24 weeks
baseline, 12 weeks, 24 weeks
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.
Time Frame: baseline, 4 weeks, 12 weeks, 24 weeks
† 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hugel

Collaborators

Associacio catalana per a la recerca oncologica i les seves implicacions sanitaries i socials

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

July 12, 2016

First Submitted That Met QC Criteria

July 13, 2016

First Posted (Estimate)

July 14, 2016

Study Record Updates

Last Update Posted (Actual)

August 8, 2017

Last Update Submitted That Met QC Criteria

August 6, 2017

Last Verified

July 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • AC-Volus-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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