Small PenisNCT03153735
Clinical Study to CMDHA0101 as Compared to PowerFill® for Temporary Penile Enhancement
A study testing CMDHA0101 and PowerFill® in people with Small Penis and Penile Enhancement, run by CHA MEDITECH Co., Ltd. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Small Penis, Penile Enhancement
- What is being tested?
- CMDHA0101 and PowerFill®
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Dec 2016to 7 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Gangdong Sacred Heart Hospital, Hallym Univ
Seoul, Gangdong-gu/Gil-dong 445, 05355
About this study
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
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.
Read the detailed description
This study was designed as a 24-week, randomized, blinded, active control trial.
If a subject signing a clinical trial agreement and satisfying the selection / exclusion criteria is enrolled in this clinical trial, he / she will receive the medical device for clinical testing at the baseline time, return to his / her home after the training . At 4 weeks, 12 weeks, and 24 weeks after the application of the medical device for clinical testing at baseline, the safety, penile girth, length, and satisfaction of the subject were evaluated. 24 weeks after application, the clinical trial sponsor (or trustee) retrieves the data necessary for the analysis of results, such as case records, for the purpose of validity and safety evaluation
- Conditions
- Small Penis, Penile Enhancement
- Being tested
- CMDHA0101, PowerFill®
- Keywords
- Hyaluronic acid, Small Penis, Penile Enhancement
- Medical subject headings
- Penis agenesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMDHA0101Device
Maximum injection dose : 22 ml
PowerFill®Device
Maximum injection dose : 22 ml
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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) Receives: Device: PowerFill® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured by value difference
Measured: baseline, 4 weeks, 12 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start2 Dec 2016
- Primary completion7 Nov 2017
- Study completion7 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small PenisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHA MEDITECH Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dae Yul Yang, Director, Study director, Hallym University Kangdong Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03153735
- Sponsor's protocol ID
- CHA-CMDHA0101
- Status last verified
- Dec 2017
- First submitted
- 5 Apr 2017
- Last updated
- 12 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03153735
- Acronym / sponsor ID
- CHA-CMDHA0101
- Conditions
- Small Penis, Penile Enhancement
- Keywords
- Hyaluronic acid, Small Penis, Penile Enhancement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- CHA MEDITECH Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Dec 2016 (actual)
- Primary completion
- 7 Nov 2017 (actual)
- Study completion
- 7 Nov 2017 (actual)
- First posted
- 15 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study was designed as a 24-week, randomized, blinded, active control trial.
If a subject signing a clinical trial agreement and satisfying the selection / exclusion criteria is enrolled in this clinical trial, he / she will receive the medical device for clinical testing at the baseline time, return to his / her home after the training . At 4 weeks, 12 weeks, and 24 weeks after the application of the medical device for clinical testing at baseline, the safety, penile girth, length, and satisfaction of the subject were evaluated. 24 weeks after application, the clinical trial sponsor (or trustee) retrieves the data necessary for the analysis of results, such as case records, for the purpose of validity and safety evaluation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CMDHA0101 | Experimental | Device: CMDHA0101Maximum injection dose : 22 ml It is a product containing 0.3% lidocaine hydrochloride, a topical anesthetic ingredient, in a crosslinked hyaluronic acid gel |
| PowerFill® | Active comparator | Device: PowerFill®Maximum injection dose : 22 ml A white solid that was lyophilized with mixed spherical PLA (Poly-D, L-lactide) microparticles and CMC (sodium carboxymethylcellulose) |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CMDHA0101Maximum injection dose : 22 ml | Device | CMDHA0101 |
| PowerFill®Maximum injection dose : 22 ml | Device | PowerFill® |
Primary outcome
The difference in value from the basal value around the penis circumference after using the test device compared to the control device
Time frame: baseline, 24 weeks
Measured by value difference
1 secondary outcome
The difference in value from the basal value around the penis circumference after using the test device compared to the control device
Time frame: baseline, 4 weeks, 12 weeks, 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dae Yul Yang, Director study director
Hallym University Kangdong Sacred Heart Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CMDHA0101 and PowerFill® in people with Small Penis and Penile Enhancement, run by CHA MEDITECH Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in value from the basal value around the penis circumference after using the test device compared to the control device (time frame: baseline, 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2017.