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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Men's Health Boston
Sponsor:
Information provided by (Responsible Party):
Dr. Abraham Morgentaler, Men's Health Boston
ClinicalTrials.gov Identifier:
NCT01578473
First received: April 12, 2012
Last updated: December 17, 2012
Last verified: December 2012

April 12, 2012
December 17, 2012
April 2012
April 2013   (final data collection date for primary outcome measure)
penile curvature [ Time Frame: 9 months ] [ Designated as safety issue: No ]
The primary outcome to be assessed will be the change in penile curvature from baseline.
Same as current
Complete list of historical versions of study NCT01578473 on ClinicalTrials.gov Archive Site
sexual function [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Secondary outcomes will incluce overall satisfaction with sexual function (patient satisfaction with treatment, quality of erections and quality of life).
Same as current
Not Provided
Not Provided
 
Testosterone Pellets Plus Vitamin D and E Versus Vitamin D and E Alone for the Treatment of Peyronie's Disease
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Peyronie's Disease
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
75
April 2013
April 2013   (final data collection date for primary outcome measure)

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
Male
18 Years to 70 Years
Yes
Contact: Tony Villanova, BS 617-277-5000 ext 122 tony@menshealthboston.com
United States
 
NCT01578473
PD Plus Study, SAIRB #201107293
Yes
Dr. Abraham Morgentaler, Men's Health Boston
Men's Health Boston
Not Provided
Principal Investigator: Abraham Morgentaler, MD Men's Health Boston
Men's Health Boston
December 2012

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