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OpenTrials
Completed

NCT Number: NCT02833532

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

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

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Key information

Conditions

Penile Enhancement

Age range

20 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

HUGEL

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male subjects aged above 20 and below 65. (20≤male≥65)
  • 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?"
  • During the study period, subjects will not received any treatments associated with penile enhancement.
  • Subjects will sign an informed consent form

Exclusion criteria

  • Prior treatment for penile enhancement (e.g. fat, dermal graft).
  • Subjects who have penile malformation (e.g. Peyronie's disease), which can make impossible to perform the intervention
  • Allergic to hyalluronic acid.
  • Inflammatory or/and infectious disease on penis that can affect on this study

Treatment and study plan

Volus/Powerfill

Device

Maximum: 22ml

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

Sponsors and collaborators

Lead sponsor

Hugel

Industry

Collaborators

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

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 14, 2016
Registry last updated
Aug 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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