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

Peyronie's Disease Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01578473
• Other study ID #: PD Plus Study
• Secondary ID: SAIRB #201107293
• Status: Completed
• Phase: Phase 1
• First received: April 12, 2012
• Last updated: March 26, 2018
• Start date: May 23, 2013
• Est. completion date: November 13, 2017

Study information

• Verified date: March 2018
• Source: Men's Health Boston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: November 13, 2017
• Est. primary completion date: July 7, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Penile Induration
• Peyronie's Disease

Intervention

Drug:
• Vitamin D2
oral softgel 2000 IU once daily 9 months
• Vitamin E
oral softgels 400 IU and 200 IU 1 softgel of 400 IU daily 1 softgel of 200 IU daily 9 months
• Testosterone Pellets
subcutaneous implantation pellets 75 mg based on testosterone levels from resulting bloodwork 9 months

Locations

Country	Name	City	State
United States	Men's Health Boston	Chestnut Hill	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Men's Health Boston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	penile curvature	The primary outcome to be assessed will be the change in penile curvature from baseline.	9 months
Secondary	sexual function	Secondary outcomes will incluce overall satisfaction with sexual function (patient satisfaction with treatment, quality of erections and quality of life).	9 months