Peyronie's Disease
Conditions
Keywords
low testosterone, penile curvature
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.
Interventions
DRUGVitamin D2
oral softgel 2000 IU once daily 9 months
DRUGVitamin E
oral softgels 400 IU and 200 IU 1 softgel of 400 IU daily 1 softgel of 200 IU daily 9 months
DRUGTestosterone Pellets
subcutaneous implantation pellets 75 mg based on testosterone levels from resulting bloodwork 9 months
Sponsors
Men's Health Boston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| penile curvature | 9 months | The primary outcome to be assessed will be the change in penile curvature from baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| sexual function | 9 months | Secondary outcomes will incluce overall satisfaction with sexual function (patient satisfaction with treatment, quality of erections and quality of life). |
Countries
United States
Outcome results
None listed