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

NCT01578473 | Completed Phase 1 DMC

• 2 other identifiers: PD Plus StudySAIRB #201107293
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Peyronie's Disease

Keywords

low testosterone; penile curvature

Outcome Measures

Primary Outcomes (1)

• penile curvature

  The primary outcome to be assessed will be the change in penile curvature from baseline.

  9 months

Secondary Outcomes (1)

• sexual function

  9 months

Study Arms (2)

Vitamin D and E

ACTIVE COMPARATOR

Oral Vitamin D and E alone in men with penile curvature due to PD.

Drug: Vitamin D2; Drug: Vitamin E

Testosterone Pellets and Vitamin D and E

ACTIVE COMPARATOR

Testosterone in combination with oral Vitamin D an E supplementation in men with penile curvature due to PD.

Drug: Testosterone Pellets

Interventions

Vitamin D2 DRUG

oral softgel 2000 IU once daily 9 months

Also known as: 21st Century Dietary Supplement

Vitamin D and E

Vitamin E DRUG

oral softgels 400 IU and 200 IU 1 softgel of 400 IU daily 1 softgel of 200 IU daily 9 months

Also known as: GERI-CARE

Vitamin D and E

Testosterone Pellets DRUG

subcutaneous implantation pellets 75 mg based on testosterone levels from resulting bloodwork 9 months

Also known as: Testopel 75 mg testosterone pellets

Testosterone Pellets and Vitamin D and E

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• prior history of treatment for PD that includes intra-lesional injections, topical creams, or surgery
• 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

Sponsors & Collaborators

• Men's Health Boston: lead

Study Sites (1)

Men's Health Boston

Chestnut Hill, Massachusetts, 02467, United States

Location

MeSH Terms

Conditions

Penile Induration

Interventions

Ergocalciferols; Vitamin E; Testosterone

Condition Hierarchy (Ancestors)

Penile Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Androstenols; Androstenes; Androstanes; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Abraham Morgentaler, MD

  Men's Health Boston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Clinical Professor of Urology Harvard Medical School

Study Record Dates

• First Submitted: April 12, 2012
• First Posted: April 17, 2012
• Study Start: May 23, 2013
• Primary Completion: July 7, 2013
• Study Completion: November 13, 2017
• Last Updated: March 29, 2018

Record last verified: 2018-03

Locations

US (1)