Penile Enhancement Clinical Trial
Official title:
A Multi-center, Randomized, Subject Blind, Active Controlled Design Clinical Study to Evaluate the Efficacy and Safety of CMDHA0101 as Compared to PowerFill® for Temporary Penile Enhancement
Verified date | December 2017 |
Source | CHA MEDITECH Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 68 |
Est. completion date | November 7, 2017 |
Est. primary completion date | November 7, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 20 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. Men over 20 years old and under 65 years of age 2. In screening, subjects' perception of penile size for dysmenorrhoea syndrome Those who responded with "small", "small", "normal", "large", "very large" 3. Persons who have agreed to discontinue other procedures or treatments for penile enlargement during the course of the trial 4. If the person is circumcised or has not undergone circumcision, A person who does not cover the glans 5. Those who have agreed to abstinence (sexual intercourse, masturbation, etc.) for at least one month after the medical device for clinical trial 6. Those who can understand and follow instructions 7. A person who voluntarily participates in the clinical trial and has agreed in writing to the subject consent form Exclusion Criteria: 1. 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. 2. 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 3. Those who have a history of bleeding in past or present time 4. Persons who are adversely affected by excessive penis enlargement, which may adversely affect the operation of the medical device 5. 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.) 6. Peyronie's disease of the penis (Peyronie's disease) malformation 7. Anaphylaxis or severe allergic symptoms. |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Gangdong Sacred Heart Hospital, Hallym Univ | Seoul City | Gangdong-gu/Gil-dong 445 |
Lead Sponsor | Collaborator |
---|---|
CHA MEDITECH Co., Ltd. |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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, 4 weeks, 12 weeks, 24 weeks |
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---|---|---|---|
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