NCT03153735

Brief Summary

The investigators aimed to confirm the efficacy and safety of transdermal penis enlargement for 24 weeks after CMDHA0101 injection in subjects who wanted penile enlargement in male patients with small-penis syndrome \*. \*Small-penis syndrome is the anxiety of thinking one's penis is too small - even though it isn't.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 2, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 15, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 7, 2017

Completed
Last Updated

December 12, 2017

Status Verified

December 1, 2017

Enrollment Period

11 months

First QC Date

April 5, 2017

Last Update Submit

December 11, 2017

Conditions

Small PenisPenile Enhancement

Keywords

Hyaluronic acidSmall PenisPenile Enhancement

Outcome Measures

Primary Outcomes (1)

  • The difference in value from the basal value around the penis circumference after using the test device compared to the control device

    Measured by value difference

    baseline, 24 weeks

Secondary Outcomes (1)

  • The difference in value from the basal value around the penis circumference after using the test device compared to the control device

    baseline, 4 weeks, 12 weeks, 24 weeks

Study Arms (2)

CMDHA0101

EXPERIMENTAL

Maximum injection dose : 22 ml It is a product containing 0.3% lidocaine hydrochloride, a topical anesthetic ingredient, in a crosslinked hyaluronic acid gel

Device: CMDHA0101

PowerFill®

ACTIVE COMPARATOR

Maximum injection dose : 22 ml A white solid that was lyophilized with mixed spherical PLA (Poly-D, L-lactide) microparticles and CMC (sodium carboxymethylcellulose)

Device: PowerFill®

Interventions

CMDHA0101DEVICE

Maximum injection dose : 22 ml

CMDHA0101
PowerFill®DEVICE

Maximum injection dose : 22 ml

PowerFill®

Eligibility Criteria

Age20 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men over 20 years old and under 65 years of age
  • In screening, subjects' perception of penile size for dysmenorrhoea syndrome Those who responded with "small", "small", "normal", "large", "very large"
  • Persons who have agreed to discontinue other procedures or treatments for penile enlargement during the course of the trial
  • If the person is circumcised or has not undergone circumcision, A person who does not cover the glans
  • Those who have agreed to abstinence (sexual intercourse, masturbation, etc.) for at least one month after the medical device for clinical trial
  • Those who can understand and follow instructions
  • A person who voluntarily participates in the clinical trial and has agreed in writing to the subject consent form

You may not qualify if:

  • A person who has received anticoagulant or antiplatelet agent within 2 weeks before application of medical device for clinical trial or Those who need to be administered until two weeks after application (However, low-dose aspirin (300 mg / day or less) is permitted.
  • A person who has received a vitamin E preparation, NSAID preparation within 1 week of application of medical device for clinical trial or Those who need to take medicine until 1 week after application
  • Those who have a history of bleeding in past or present time
  • Persons who are adversely affected by excessive penis enlargement, which may adversely affect the operation of the medical device
  • Those who have undergone penis enlargement surgery (fat, alternative dermatologic transplantation) in the past (except for hyaluronic acid or collagen. Two years after transplantation and extension of the penis, such as suprapubic fat preparation and suspension ligament resection In the case of surgery, it is allowed.)
  • Peyronie's disease of the penis (Peyronie's disease) malformation
  • Anaphylaxis or severe allergic symptoms.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gangdong Sacred Heart Hospital, Hallym Univ

Seoul, Gangdong-gu/Gil-dong 445, 05355, South Korea

Location

MeSH Terms

Conditions

Penis agenesis

Study Officials

  • Dae Yul Yang, Director

    Hallym University Kangdong Sacred Heart Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Subject blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2017

First Posted

May 15, 2017

Study Start

December 2, 2016

Primary Completion

November 7, 2017

Study Completion

November 7, 2017

Last Updated

December 12, 2017

Record last verified: 2017-12

Locations

KR(1)