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

Condition(s) targeted: Peyronie's Disease

Intervention: Vitamin D2 (Drug); Vitamin E (Drug); Testosterone Pellets (Drug)

Phase: Phase 1

Status: Active, not recruiting

Sponsored by: Men's Health Boston

Official(s) and/or principal investigator(s):
Abraham Morgentaler, MD, Principal Investigator, Affiliation: Men's Health Boston

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: penile curvature

Secondary outcome: sexual function

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Male.

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

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

Starting date: April 2012
Last updated: April 8, 2015