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

Primary Purpose

Peyronie's Disease

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Vitamin D2

Vitamin E

Testosterone Pellets

About this trial

This is an interventional treatment trial for Peyronie's Disease focused on measuring low testosterone, penile curvature

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Men's Health Boston

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Vitamin D and E

Testosterone Pellets and Vitamin D and E

Arm Description

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

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

Outcomes

Primary Outcome Measures

penile curvature

The primary outcome to be assessed will be the change in penile curvature from baseline.

Secondary Outcome Measures

sexual function

Secondary outcomes will incluce overall satisfaction with sexual function (patient satisfaction with treatment, quality of erections and quality of life).

Full Information

NCT ID

NCT01578473

First Posted

April 12, 2012

Last Updated

March 26, 2018

Sponsor

Men's Health Boston

1. Study Identification

Unique Protocol Identification Number

NCT01578473

Brief Title

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

Acronym

PD+

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

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

May 23, 2013 (Actual)

Primary Completion Date

July 7, 2013 (Actual)

Study Completion Date

November 13, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Men's Health Boston

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peyronie's Disease

Keywords

low testosterone, penile curvature

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

75 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vitamin D and E

Arm Type

Active Comparator

Arm Description

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

Arm Title

Testosterone Pellets and Vitamin D and E

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Vitamin D2

Other Intervention Name(s)

21st Century Dietary Supplement

Intervention Description

oral softgel 2000 IU once daily 9 months

Intervention Type

Drug

Intervention Name(s)

Vitamin E

Other Intervention Name(s)

GERI-CARE

Intervention Description

oral softgels 400 IU and 200 IU 1 softgel of 400 IU daily 1 softgel of 200 IU daily 9 months

Intervention Type

Drug

Intervention Name(s)

Testosterone Pellets

Other Intervention Name(s)

Testopel 75 mg testosterone pellets

Intervention Description

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

Primary Outcome Measure Information:

Title

penile curvature

Description

The primary outcome to be assessed will be the change in penile curvature from baseline.

Time Frame

9 months

Secondary Outcome Measure Information:

Title

sexual function

Description

Secondary outcomes will incluce overall satisfaction with sexual function (patient satisfaction with treatment, quality of erections and quality of life).

Time Frame

9 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Abraham Morgentaler, MD

Organizational Affiliation

Men's Health Boston

Official's Role

Principal Investigator

Facility Information:

Facility Name

Men's Health Boston

City

Chestnut Hill

State/Province

Massachusetts

ZIP/Postal Code

02467

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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