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
  Purpose

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.


Condition Intervention Phase
Peyronie's Disease
Drug: Vitamin D2
Drug: Vitamin E
Drug: Testosterone Pellets
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Men's Health Boston:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Estimated Enrollment: 75
Study Start Date: April 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vitamin D and E
Oral Vitamin D and E alone in men with penile curvature due to PD.
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
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.
Drug: Testosterone Pellets
subcutaneous implantation pellets 75 mg based on testosterone levels from resulting bloodwork 9 months
Other Name: Testopel 75 mg testosterone pellets

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01578473

Contacts
Contact: Tony Villanova, BS 617-277-5000 ext 122 tony@menshealthboston.com

Locations
United States, Massachusetts
Men's Health Boston Recruiting
Brookline, Massachusetts, United States, 02445
Principal Investigator: Abraham Morgentaler, MD         
Sponsors and Collaborators
Men's Health Boston
Investigators
Principal Investigator: Abraham Morgentaler, MD Men's Health Boston
  More Information

No publications provided

Responsible Party: Dr. Abraham Morgentaler, Associate Clinical Professor of Urology Harvard Medical School, Men's Health Boston
ClinicalTrials.gov Identifier: NCT01578473     History of Changes
Other Study ID Numbers: PD Plus Study, SAIRB #201107293
Study First Received: April 12, 2012
Last Updated: December 17, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Men's Health Boston:
low testosterone
penile curvature

Additional relevant MeSH terms:
Penile Diseases
Penile Induration
Connective Tissue Diseases
Genital Diseases, Male
Ergocalciferols
Methyltestosterone
Testosterone
Testosterone 17 beta-cypionate
Testosterone enanthate
Testosterone undecanoate
Vitamin D
Vitamins
Anabolic Agents
Androgens
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Bone Density Conservation Agents
Growth Substances
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014