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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-23

Study Completion Date

2017-11-13

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.

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Detailed Description

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Conditions

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Peyronie's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vitamin D and E

Oral Vitamin D and E alone in men with penile curvature due to PD.

Group Type ACTIVE_COMPARATOR

Vitamin D2

Intervention Type DRUG

oral softgel 2000 IU once daily 9 months

Vitamin E

Intervention Type DRUG

oral softgels 400 IU and 200 IU 1 softgel of 400 IU daily

1 softgel of 200 IU daily 9 months

Testosterone Pellets and Vitamin D and E

Testosterone in combination with oral Vitamin D an E supplementation in men with penile curvature due to PD.

Group Type ACTIVE_COMPARATOR

Testosterone Pellets

Intervention Type DRUG

subcutaneous implantation pellets 75 mg based on testosterone levels from resulting bloodwork 9 months

Interventions

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Vitamin D2

oral softgel 2000 IU once daily 9 months

Intervention Type DRUG

Vitamin E

oral softgels 400 IU and 200 IU 1 softgel of 400 IU daily

1 softgel of 200 IU daily 9 months

Intervention Type DRUG

Testosterone Pellets

subcutaneous implantation pellets 75 mg based on testosterone levels from resulting bloodwork 9 months

Intervention Type DRUG

Other Intervention Names

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21st Century Dietary Supplement GERI-CARE Testopel 75 mg testosterone pellets

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes