MicropenisNCT04755634
Shafer Width and Girth: The Use of Injectable Fillers for Penile Enhancement
A study testing Hyaluronic Acid in people with Micropenis, run by Shafer Clinic Fifth Avenue at 1 site in United States.
Trial summary
Injectable filler will be performed by Principal Investigator under sterile conditions for the enhancement of girth and surface area of the penis. Read more about this study
- Who is it for?
- Ages 21 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Micropenis
- What is being tested?
- Hyaluronic Acid
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2021to 27 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males,
- 21 to 65 years of age,
- Seeking enhancement of their penile width and girth.
Who cannot join
- Patient with a history of psychological or psychiatric illness,
- Congenital or acquired penile malformation,
- Previous plastic surgery or non-invasive treatments of their penis,
- Any chronic disease such as vascular disorder, urological disorder, myocardial infarction, hypertension, cerebrovascular accident or coagulopathy.
- Patients with a history of allergic reactions to hyaluronic acid derivatives
- Individuals with penises measured less than 6 cm in length in the flaccid position
- Individuals with penises greater than 12.5 cm in length in the flaccid position.
- Individuals with uncircumcised penises
Trial locations and contacts
1 site in 1 country.
United States1 site
Shafer Clinic Fifth Avenue
New York, New York, 10017
About this study
Injectable filler will be performed by Principal Investigator under sterile conditions for the enhancement of girth and surface area of the penis.
Read the detailed description
This prospective, single-arm, single-center study was conducted to evaluate the efficacy and safety of injectable dermal fillers for penile enhancement.
Prior to enrollment, each participant underwent a comprehensive consultation and provided written informed consent after receiving detailed information regarding the study objectives, procedures, potential risks, benefits, and available alternatives.
Following baseline evaluation (Day 1), including standardized photographic documentation and penile measurements, the procedure was performed under sterile conditions in an office-based setting by the Principal Investigator. Topical anesthesia was applied for approximately 10 minutes, after which participants were placed in supine position. A dorsal penile nerve block was administered using local anesthesia, followed by injections of study filler.
Participants returned approximately two weeks after the initial treatment for an additional treatment session, when clinically indicated to achieve the planned treatment goal. Follow-up evaluations were conducted at 2, 6, 12 weeks, and at 1year after treatment.
The primary efficacy endpoint was change in penile shaft girth from baseline. Safety assessments included systemic monitoring and documentation of treatment-related adverse events throughout the study period.
The study was conducted in accordance with the principles of the International Council for Harmonization Good Clinical Practice (ICH GCP) guidelines and was reviewed and overseen by the Institutional Review Board (IRB), Advarra.
- Conditions
- Micropenis
- Being tested
- Hyaluronic Acid
- Medical subject headings
- Penis agenesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic AcidDevice
Injectable
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | This is a prospective, single-arm, single-center study Receives: Device: Hyaluronic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Penile Shaft Girth at 1 Year
Penile Shaft Girth was measured in centimeters at baseline and at the1-year post-treatment follow-up. Change from baseline was calculated as the penile shaft girth at the 1-year follow-up minus the penile shaft girth at baseline. Positive values indicate an increase in penile shaft girth, and negative values indicate a decrease.
Measured: Baseline and 1-year post-treatment follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start23 Apr 2021
- Primary completion27 Jun 2024
- Study completion27 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MicropenisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shafer Clinic Fifth Avenue
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- David Shafer, MD, Principal investigator, Shafer Clinic Fifth Avenue
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04755634
- Sponsor's protocol ID
- Pro00034295
- Status last verified
- Jul 2026
- First submitted
- 10 Feb 2021
- Last updated
- 18 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shafer Width and Girth: The Use of Injectable Fillers for Penile Enhancement
- ClinicalTrials.gov ID
- NCT04755634
- Acronym / sponsor ID
- Pro00034295
- Conditions
- Micropenis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Shafer Clinic Fifth AvenueResearch network
- Study start
- 23 Apr 2021 (actual)
- Primary completion
- 27 Jun 2024 (actual)
- Study completion
- 27 Jun 2024 (actual)
- First posted
- 16 Feb 2021 (actual)
- Results
- Posted 18 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Injectable filler will be performed by Principal Investigator under sterile conditions for the enhancement of girth and surface area of the penis.
Detailed description
This prospective, single-arm, single-center study was conducted to evaluate the efficacy and safety of injectable dermal fillers for penile enhancement.
Prior to enrollment, each participant underwent a comprehensive consultation and provided written informed consent after receiving detailed information regarding the study objectives, procedures, potential risks, benefits, and available alternatives.
Following baseline evaluation (Day 1), including standardized photographic documentation and penile measurements, the procedure was performed under sterile conditions in an office-based setting by the Principal Investigator. Topical anesthesia was applied for approximately 10 minutes, after which participants were placed in supine position. A dorsal penile nerve block was administered using local anesthesia, followed by injections of study filler.
Participants returned approximately two weeks after the initial treatment for an additional treatment session, when clinically indicated to achieve the planned treatment goal. Follow-up evaluations were conducted at 2, 6, 12 weeks, and at 1year after treatment.
The primary efficacy endpoint was change in penile shaft girth from baseline. Safety assessments included systemic monitoring and documentation of treatment-related adverse events throughout the study period.
The study was conducted in accordance with the principles of the International Council for Harmonization Good Clinical Practice (ICH GCP) guidelines and was reviewed and overseen by the Institutional Review Board (IRB), Advarra.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Device: Hyaluronic AcidThis is a prospective, single-arm, single-center study |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy males,
- 21 to 65 years of age,
- Seeking enhancement of their penile width and girth.
Key exclusion criteria (8 listed)
- Patient with a history of psychological or psychiatric illness,
- Congenital or acquired penile malformation,
- Previous plastic surgery or non-invasive treatments of their penis,
- Any chronic disease such as vascular disorder, urological disorder, myocardial infarction, hypertension, cerebrovascular accident or coagulopathy.
- Patients with a history of allergic reactions to hyaluronic acid derivatives
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 |
|---|---|---|
| Hyaluronic AcidInjectable | Device | Single Arm |
Primary outcome
Change From Baseline in Penile Shaft Girth at 1 Year
Time frame: Baseline and 1-year post-treatment follow-up
Penile Shaft Girth was measured in centimeters at baseline and at the1-year post-treatment follow-up. Change from baseline was calculated as the penile shaft girth at the 1-year follow-up minus the penile shaft girth at baseline. Positive values indicate an increase in penile shaft girth, and negative values indicate a decrease.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
David Shafer, MD principal investigator
Shafer Clinic Fifth Avenue
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyaluronic Acid in people with Micropenis, run by Shafer Clinic Fifth Avenue at 1 site in United States.
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 3 inclusion and 8 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 18 Aug 2026. 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 United States. 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?
Yes. Results are posted in the registry (first posted 18 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Penile Shaft Girth at 1 Year (time frame: Baseline and 1-year post-treatment follow-up). 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 18 Aug 2026.