Penile ElongationNCT04231422
A Proof of Concept Top Evaluate a Novel Penile Lengthening Protocol
An observational study of Penile Elongation, run by Judson Brandeis at 1 site in United States.
Trial summary
The objective of this study is to examine and quantify the efficacy and safety of a new treatment protocol using platelet-rich plasma for penile length enhancement. Read more about this study
- Who is it for?
- Ages 20 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Penile Elongation
- What is being tested?
- Platelet-rich plasma
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2019to 12 Jul 2021
- Phase
- Observational
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Study participants comprised of men with a desire for penile elongation.
Who may be able to join
- Stretched penile length between 3.5 - 8.0 in
- Age 20-55 years of age
- Desire penile length elongation
- Willing to complete all aspects of combined treatment plan
- Able to measure erect penile length and mid-shaft girth at 1-month intervals
- Judged to be in good health based on medical history, physical exam, and laboratory profile
- Is willing and able to cooperate with the requirement of the study (e.g. completion of all planned study visits)
Who cannot join
- No prior surgical Peyronie's disease treatment
- No chordee with or without hypospadias
- No infiltration by benign or malignant mass
- No active STD
- No infiltration by an infectious agent such as lymphogranuloma venereum
- No uncontrolled psychiatric conditions
Show all 14Show fewer
- No uncontrolled neurologic conditions
- No other uncontrolled medical conditions such as HTN or DM
- No history of spontaneous priapism
- Is unable to safely use the study devices as determined by the principal investigator
- No thrombosis of the dorsal penile artery or vein
- No known history of coagulation disorder
- No known history of stroke, bleeding, or another significant medical conditional which the investigator deems makes the subject unsuitable for enrollment in the study
- Testosterone level lower than 500
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
BrandeisMD
San Ramon, California, 94583
Judson Brandeis, MD, 510-587-3000, Judson@BrandeisMD.com
Scott Lu
About this study
The objective of this study is to examine and quantify the efficacy and safety of a new treatment protocol using platelet-rich plasma for penile length enhancement.
- Conditions
- Penile Elongation
- Being tested
- Platelet-rich plasma
- Keywords
- platelet-rich plasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-rich plasmaCombination product
12mL of platelet-rich plasma injected into cavernosal bodies bilaterally
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Monthly intracavernosal platelet-rich plasma injection + daily physical manipulation. Receives: Combination Product: Platelet-rich plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stretched penile length
Change in length of stretched, flaccid penile length
Measured: baseline to six months
Secondary outcomes (3)
SHIM Score
Change in erectile function
Measured: baseline to six months
BDD-YBOCS
Change in body dysmorphia scale
Measured: baseline to six months
Safety Measurement
Incidence of adverse events and serious adverse events
Measured: baseline to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start12 Nov 2019
- Primary completion12 May 2021 (estimated)
- Study completion12 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Penile ElongationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Judson Brandeis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Judson Brandeis, BrandeisMD
- Investigators
- Judson Brandeis, MD, Principal investigator, BrandeisMD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04231422
- Sponsor's protocol ID
- BRAND-003
- Status last verified
- Jan 2020
- First submitted
- 14 Jan 2020
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- 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 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof of Concept Top Evaluate a Novel Penile Lengthening Protocol
- ClinicalTrials.gov ID
- NCT04231422
- Acronym / sponsor ID
- BRAND-003
- Conditions
- Penile Elongation
- Keywords
- platelet-rich plasma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Judson BrandeisIndustry (pharma, biotech, devices)
- Study start
- 12 Nov 2019 (actual)
- Primary completion
- 12 May 2021 (estimated)
- Study completion
- 12 Jul 2021 (estimated)
- First posted
- 18 Jan 2020 (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 objective of this study is to examine and quantify the efficacy and safety of a new treatment protocol using platelet-rich plasma for penile length enhancement.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | – | Combination Product: Platelet-rich plasmaMonthly intracavernosal platelet-rich plasma injection + daily physical manipulation. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Study participants comprised of men with a desire for penile elongation.
Key inclusion criteria (7 listed)
- Stretched penile length between 3.5 - 8.0 in
- Age 20-55 years of age
- Desire penile length elongation
- Willing to complete all aspects of combined treatment plan
- Able to measure erect penile length and mid-shaft girth at 1-month intervals
Key exclusion criteria (14 listed)
- No prior surgical Peyronie's disease treatment
- No chordee with or without hypospadias
- No infiltration by benign or malignant mass
- No active STD
- No infiltration by an infectious agent such as lymphogranuloma venereum
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 |
|---|---|---|
| Platelet-rich plasma12mL of platelet-rich plasma injected into cavernosal bodies bilaterally | Combination product | Treatment Group |
Primary outcome
Stretched penile length
Time frame: baseline to six months
Change in length of stretched, flaccid penile length
3 secondary outcomes
SHIM Score
Time frame: baseline to six months
BDD-YBOCS
Time frame: baseline to six months
Safety Measurement
Time frame: baseline to six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Individual participant dataSharing planned: Undecided
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.
Judson Brandeis, MD principal investigator
BrandeisMD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Penile Elongation, run by Judson Brandeis 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 7 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 18 Jan 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Judson Brandeis, MD (510-587-3000, Judson@BrandeisMD.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stretched penile length (time frame: baseline to six months). 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 Jan 2020.