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

Study Overview
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Brief Summary
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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
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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

Conditions
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Peyronie's Disease

Intervention / Treatment
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* Drug: Vitamin D2
* Drug: Vitamin E
* Drug: Testosterone Pellets


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vitamin D and E<br>Oral Vitamin D and E alone in men with penile curvature due to PD. | Drug: Vitamin D2<br>* oral softgel 2000 IU once daily 9 months<br>* Other names: 21st Century Dietary Supplement;Drug: Vitamin E<br>* oral softgels 400 IU and 200 IU 1 softgel of 400 IU daily 1 softgel of 200 IU daily 9 months<br>* Other names: GERI-CARE;|
| Active Comparator: Testosterone Pellets and Vitamin D and E<br>Testosterone in combination with oral Vitamin D an E supplementation in men with penile curvature due to PD. | Drug: Testosterone Pellets<br>* subcutaneous implantation pellets 75 mg based on testosterone levels from resulting bloodwork 9 months<br>* Other names: Testopel 75 mg testosterone pellets;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| penile curvature | The primary outcome to be assessed will be the change in penile curvature from baseline. | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sexual function | Secondary outcomes will incluce overall satisfaction with sexual function (patient satisfaction with treatment, quality of erections and quality of life). | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low testosterone, penile curvature