Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Testosterone Pellets Plus Vitamin D and E Versus Vitamin D and E Alone for the Treatment of Peyronie's Disease (PD+)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01578473
Recruitment Status : Completed
First Posted : April 17, 2012
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Abraham Morgentaler, Men's Health Boston

Tracking Information
First Submitted Date  ICMJE April 12, 2012
First Posted Date  ICMJE April 17, 2012
Last Update Posted Date March 29, 2018
Actual Study Start Date  ICMJE May 23, 2013
Actual Primary Completion Date July 7, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2012)
penile curvature [ Time Frame: 9 months ]
The primary outcome to be assessed will be the change in penile curvature from baseline.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01578473 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2012)
sexual function [ Time Frame: 9 months ]
Secondary outcomes will incluce overall satisfaction with sexual function (patient satisfaction with treatment, quality of erections and quality of life).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Testosterone Pellets Plus Vitamin D and E Versus Vitamin D and E Alone for the Treatment of Peyronie's Disease
Official Title  ICMJE An Open-Label, Nine-Month Randomized Controlled Study of Testosterone (Testopel) Pellets Plus Vitamin D and E Versus Vitamin D and E Alone for the Treatment of Peyronie's Disease
Brief Summary Two recent studies have identified low levels of serum testosterone in association with Peyronie's Disease (PD), with a significant correlation noted between severity of testosterone deficiency and severity of curvature. The study hypothesis is to determine whether treatment with testosterone may help men with PD and penile curvature.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Peyronie's Disease
Intervention  ICMJE
  • Drug: Vitamin D2
    oral softgel 2000 IU once daily 9 months
    Other Name: 21st Century Dietary Supplement
  • Drug: Vitamin E

    oral softgels 400 IU and 200 IU 1 softgel of 400 IU daily

    1 softgel of 200 IU daily 9 months

    Other Name: GERI-CARE
  • Drug: Testosterone Pellets
    subcutaneous implantation pellets 75 mg based on testosterone levels from resulting bloodwork 9 months
    Other Name: Testopel 75 mg testosterone pellets
Study Arms  ICMJE
  • Active Comparator: Vitamin D and E
    Oral Vitamin D and E alone in men with penile curvature due to PD.
    Interventions:
    • Drug: Vitamin D2
    • Drug: Vitamin E
  • Active Comparator: Testosterone Pellets and Vitamin D and E
    Testosterone in combination with oral Vitamin D an E supplementation in men with penile curvature due to PD.
    Intervention: Drug: Testosterone Pellets
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  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 16, 2012)
75
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 13, 2017
Actual Primary Completion Date July 7, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • acquired penile curvature of > 30 degrees and < 90 degrees associated with palpable penile plaque on physical examination
  • onset of curvature within 18 months prior to signing consent form
  • serum TT < 500 ng/dl at the screening visit

Exclusion Criteria:

  • prior history of treatment for PD that includes intra-lesional injections, topical creams, or surgery
  • prior treatment with oral therapy at least 2 weeks prior to signing consent form (e.g. Potaba, Vitamin E, colchicines) will be acceptable for inclusion
  • prior history of treatment for testosterone deficiency
  • presence of dense calcified plaque by US or plain radiograph
  • taking the medication Coumadin
  • hypersensitivity to testosterone, stearic acid, or polyvinyl pyrolidone (the constituents of Testopel)
  • unable to achieve adequate erection with penile injection to access degree of curvature
  • undergone definitive treatment for prostate cancer, bladder cancer, or other pelvic malignancies including surgery, external beam radiation therapy, brachytherapy, cryotherapy.
  • prior history of prostate cancer, hematologic disorders, chronic liver disease including cirrhosis and hepatitis C, disorders affecting the immune system, including infection with human immunodeficiency virus, or psychiatric disorders including major depression, schizophrenia, bipolar disease
  • history of cerebrovascular accident, history of deep venous thrombosis within the past 5 years or history of untreated or severe sleep apnea
  • PSA > 4.0 ng/dL at the screening visit, unless prostate cancer has been excluded to the investigator's satisfaction
  • clinically significant abnormal lab results that would put the subject at increased risk or compromise the integrity of the study data, in the opinion of the investigator
  • received any other investigational drug within 30 days
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01578473
Other Study ID Numbers  ICMJE PD Plus Study
SAIRB #201107293 ( Other Identifier: Schulman Associates Institutional Review Board, Inc. )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Abraham Morgentaler, Men's Health Boston
Study Sponsor  ICMJE Men's Health Boston
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Abraham Morgentaler, MD Men's Health Boston
PRS Account Men's Health Boston
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP