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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2015 by Dr. Abraham Morgentaler, Men's Health Boston.
Recruitment status was:  Active, not recruiting
Information provided by (Responsible Party):
Dr. Abraham Morgentaler, Men's Health Boston Identifier:
First received: April 12, 2012
Last updated: April 8, 2015
Last verified: April 2015
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
Intervention Model: Parallel Assignment
Masking: None (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 Dr. Abraham Morgentaler, Men's Health Boston:

Primary Outcome Measures:
  • penile curvature [ Time Frame: 9 months ]
    The primary outcome to be assessed will be the change in penile curvature from baseline.

Secondary Outcome Measures:
  • 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).

Estimated Enrollment: 75
Study Start Date: April 2012
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: December 2016 (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


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT01578473

United States, Massachusetts
Men's Health Boston
Chestnut Hill, Massachusetts, United States, 02467
Sponsors and Collaborators
Men's Health Boston
Principal Investigator: Abraham Morgentaler, MD Men's Health Boston
  More Information

Responsible Party: Dr. Abraham Morgentaler, Associate Clinical Professor of Urology Harvard Medical School, Men's Health Boston Identifier: NCT01578473     History of Changes
Other Study ID Numbers: PD Plus Study
SAIRB #201107293 ( Other Identifier: Schulman Associates Institutional Review Board, Inc. )
Study First Received: April 12, 2012
Last Updated: April 8, 2015

Keywords provided by Dr. Abraham Morgentaler, Men's Health Boston:
low testosterone
penile curvature

Additional relevant MeSH terms:
Penile Induration
Penile Diseases
Genital Diseases, Male
Connective Tissue Diseases
Vitamin D
Vitamin E
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents processed this record on September 21, 2017