Recruiting

Penile Lengthening

Sponsor:

Judson Brandeis

Code:

NCT04231422

Conditions

Penile Elongation

Eligibility Criteria

Sex: Male

Age: 20 - 55

Healthy Volunteers: Accepted

Interventions

Platelet-rich plasma

Study Details

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.

Conditions

Penile Elongation

Study ID

NCT04231422

Start date

Nov 12, 2019

Status verified date

Jan, 2020

Completion date

Jul 12, 2021

Anticipated

Primary completion date

May 12, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 20 - 55

Healthy Volunteers: Accepted

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

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

Treatment Group

Monthly intracavernosal platelet-rich plasma injection + daily physical manipulation.

Interventions

Platelet-rich plasma

12mL of platelet-rich plasma injected into cavernosal bodies bilaterally

Primary outcome measure

  • Stretched penile length [ Time Frame: baseline to six months ]

Central Contacts and Locations

Central contacts

Locations

BrandeisMD

Recruiting

San Ramon, California, United States, 94583

Contacts

More Information

Sponsor

Judson Brandeis

Last update posted

Jan 18, 2020

Last verified

Jan, 2020

Keywords

  • platelet-rich plasma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Judson Brandeis on 2020-01-18.