Clinical trial NCT01578473: Testosterone Pellets Plus Vitamin D and E Versus Vitamin D and E Alone for the Treatment of Peyronie's Disease
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Peyronie's Disease
Keywords: low testosterone
penile curvature
Lead sponsor: Men's Health Boston
Sponsor class: OTHER
First posted: 2012-04-17
Enrollment: 75
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: penile curvature
timeFrame: 9 months
Secondary outcomes:
measure: sexual function
timeFrame: 9 months
Other outcomes:
Locations:
city: Chestnut Hill
country: United States
facility: Men's Health Boston
state: Massachusetts
Study officials:
affiliation: Men's Health Boston
name: Abraham Morgentaler, MD
role: PRINCIPAL_INVESTIGATOR
References: