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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 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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Peyronie's Disease Drug: Vitamin D2 Drug: Vitamin E Drug: Testosterone Pellets Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
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
Actual Study Start Date : May 23, 2013
Actual Primary Completion Date : July 7, 2013
Actual Study Completion Date : November 13, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


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


Secondary Outcome Measures :
  1. 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01578473


Locations
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United States, Massachusetts
Men's Health Boston
Chestnut Hill, Massachusetts, United States, 02467
Sponsors and Collaborators
Men's Health Boston
Investigators
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Principal Investigator: Abraham Morgentaler, MD Men's Health Boston
More Information
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Responsible Party: Dr. Abraham Morgentaler, Associate Clinical Professor of Urology Harvard Medical School, Men's Health Boston
ClinicalTrials.gov Identifier: NCT01578473    
Other Study ID Numbers: PD Plus Study
SAIRB #201107293 ( Other Identifier: Schulman Associates Institutional Review Board, Inc. )
First Posted: April 17, 2012    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Keywords provided by Dr. Abraham Morgentaler, Men's Health Boston:
low testosterone
penile curvature
Additional relevant MeSH terms:
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Penile Induration
Penile Diseases
Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Male Urogenital Diseases
Connective Tissue Diseases
Vitamin D
Ergocalciferols
Vitamins
Vitamin E
Methyltestosterone
Testosterone
Testosterone undecanoate
Testosterone enanthate
 Testosterone 17 beta-cypionate
Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Calcium-Regulating Hormones and Agents