Peyronie's Disease Vitamin D
Testosterone Pellets Plus Vitamin D and E Versus Vitamin D and E Alone for the Treatment of Peyronie's Disease (PD+)
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| ClinicalTrials.gov Identifier: NCT01578473 |
| Recruitment Status : Completed First Posted : April 17, 2012 Last Update Posted : March 29, 2018 |
Sponsor:
Men's Health Boston
Information provided by (Responsible Party):
Dr. Abraham Morgentaler, Men's Health Boston
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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 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 
| 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 |
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).
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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
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
| United States, Massachusetts | |
| Men's Health Boston | |
| Chestnut Hill, Massachusetts, United States, 02467 | |
Sponsors and Collaborators
Men's Health Boston
Investigators
| Principal Investigator: | Abraham Morgentaler, MD | Men's Health Boston |
| 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:
| Penile Induration Penile 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 |
Source: https://clinicaltrials.gov/ct2/show/NCT01578473
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