Efficacy and Safety of Potenfill for Temporary Penile Enhancement

NCT ID: NCT03512717

Last Updated: 2019-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-16

Study Completion Date

2018-07-31

Brief Summary

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The purpose of this study is to evlauate the efficacy and safety of poteinfill, compared to the powerfill.

Detailed Description

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Conditions

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Penile Enhancement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Potenfill

Group Type EXPERIMENTAL

Potenfill

Intervention Type DEVICE

Maximum: 22ml

Powerfill

Group Type ACTIVE_COMPARATOR

Powerfill

Intervention Type DEVICE

Maximum: 22ml

Interventions

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Potenfill

Maximum: 22ml

Intervention Type DEVICE

Powerfill

Maximum: 22ml

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Male subjects aged above 19 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. 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
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Medy-Tox

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Gangdong Sacred Heart Hospital, Hallym Univ

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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MT05-KR17PGE308

Identifier Type: -

Identifier Source: org_study_id

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