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

Phase 1

Completed

• Conditions: Peyronie's Disease
• Interventions: Drug: Testosterone Pellets; Drug: Vitamin D2; Drug: Vitamin E

• Registration Number: NCT01578473
• Lead Sponsor: Men's Health Boston

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-12
• Study First Submitted QC: 2012-04-16
• Study First Posted: 2012-04-17
• Study Start: 2013-05-23
• Primary Completion: 2013-07-07
• Study Completion: 2017-11-13
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-26
• Last Update Posted: 2018-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Testosterone Pellets and Vitamin D and E	Testosterone Pellets	Testosterone in combination with oral Vitamin D an E supplementation in men with penile curvature due to PD.
Vitamin D and E	Vitamin E	Oral Vitamin D and E alone in men with penile curvature due to PD.
Vitamin D and E	Vitamin D2	Oral Vitamin D and E alone in men with penile curvature due to PD.

Primary Outcome Measures

Name	Time	Method
penile curvature	9 months	The primary outcome to be assessed will be the change in penile curvature from baseline.

Secondary Outcome Measures

Name	Time	Method
sexual function	9 months	Secondary outcomes will incluce overall satisfaction with sexual function (patient satisfaction with treatment, quality of erections and quality of life).

Trial Locations

Locations (1)

Men's Health Boston; 🇺🇸 Chestnut Hill, Massachusetts, United States