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

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.

Study Overview

• Status: Completed
• Conditions: Peyronie's Disease
• Intervention / Treatment: Drug: Vitamin D2; Drug: Vitamin E; Drug: Testosterone Pellets

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Chestnut Hill, Massachusetts, United States, 02467
      • Men's Health Boston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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 Names: Testopel 75 mg testosterone pellets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
penile curvature	The primary outcome to be assessed will be the change in penile curvature from baseline.	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sexual function	Secondary outcomes will incluce overall satisfaction with sexual function (patient satisfaction with treatment, quality of erections and quality of life).	9 months

Collaborators and Investigators

• Sponsor: Men's Health Boston

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2013
• Primary Completion (Actual): July 7, 2013
• Study Completion (Actual): November 13, 2017

Study Registration Dates

• First Submitted: April 12, 2012
• First Submitted That Met QC Criteria: April 16, 2012
• First Posted (Estimate): April 17, 2012

Study Record Updates

• Last Update Posted (Actual): March 29, 2018
• Last Update Submitted That Met QC Criteria: March 26, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: low testosterone; penile curvature
• Additional Relevant MeSH Terms: Connective Tissue Diseases; Penile Diseases; Penile Induration; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protective Agents; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Antioxidants; Androgens; Anabolic Agents; Vitamin D; Vitamin E; Vitamins; Testosterone; Ergocalciferols; Methyltestosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
• Other Study ID Numbers: PD Plus Study; SAIRB #201107293 (Other Identifier: Schulman Associates Institutional Review Board, Inc.)