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A Proof of Concept Top Evaluate a Novel Penile Lengthening Protocol

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ClinicalTrials.gov Identifier: NCT04231422
Recruitment Status : Recruiting
First Posted : January 18, 2020
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Judson Brandeis, BrandeisMD

Tracking Information
First Submitted Date January 14, 2020
First Posted Date January 18, 2020
Last Update Posted Date January 18, 2020
Actual Study Start Date November 12, 2019
Estimated Primary Completion Date May 12, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 14, 2020)
Stretched penile length [ Time Frame: baseline to six months ]
Change in length of stretched, flaccid penile length
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: January 14, 2020)
  • SHIM Score [ Time Frame: baseline to six months ]
    Change in erectile function
  • BDD-YBOCS [ Time Frame: baseline to six months ]
    Change in body dysmorphia scale
  • Safety Measurement [ Time Frame: baseline to six months ]
    Incidence of adverse events and serious adverse events
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Proof of Concept Top Evaluate a Novel Penile Lengthening Protocol
Official Title A Proof of Concept Top Evaluate a Novel Penile Lengthening Protocol
Brief 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Study participants comprised of men with a desire for penile elongation.
Condition Penile Elongation
Intervention Combination Product: Platelet-rich plasma
12mL of platelet-rich plasma injected into cavernosal bodies bilaterally
Study Groups/Cohorts Treatment Group
Monthly intracavernosal platelet-rich plasma injection + daily physical manipulation.
Intervention: Combination Product: Platelet-rich plasma
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 14, 2020)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 12, 2021
Estimated Primary Completion Date May 12, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Stretched penile length between 3.5 - 8.0 in
  2. Age 20-55 years of age
  3. Desire penile length elongation
  4. Willing to complete all aspects of combined treatment plan
  5. Able to measure erect penile length and mid-shaft girth at 1-month intervals
  6. Judged to be in good health based on medical history, physical exam, and laboratory profile
  7. Is willing and able to cooperate with the requirement of the study (e.g. completion of all planned study visits)

Exclusion Criteria:

  1. No prior surgical Peyronie's disease treatment
  2. No chordee with or without hypospadias
  3. No infiltration by benign or malignant mass
  4. No active STD
  5. No infiltration by an infectious agent such as lymphogranuloma venereum
  6. No uncontrolled psychiatric conditions
  7. No uncontrolled neurologic conditions
  8. No other uncontrolled medical conditions such as HTN or DM
  9. No history of spontaneous priapism
  10. Is unable to safely use the study devices as determined by the principal investigator
  11. No thrombosis of the dorsal penile artery or vein
  12. No known history of coagulation disorder
  13. No known history of stroke, bleeding, or another significant medical conditional which the investigator deems makes the subject unsuitable for enrollment in the study
  14. Testosterone level lower than 500
Sex/Gender
Sexes Eligible for Study: Male
Ages 20 Years to 55 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Judson Brandeis, MD 510-587-3000 Judson@BrandeisMD.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04231422
Other Study ID Numbers BRAND-003
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Judson Brandeis, BrandeisMD
Study Sponsor Judson Brandeis
Collaborators Not Provided
Investigators
Principal Investigator: Judson Brandeis, MD BrandeisMD
PRS Account BrandeisMD
Verification Date January 2020