This trial is active, not recruiting.

Condition peyronie's disease
Treatments vitamin d2, vitamin e, testosterone pellets
Phase phase 1
Sponsor Men's Health Boston
Start date April 2012
End date December 2016
Trial size 75 participants
Trial identifier NCT01578473, PD Plus Study, SAIRB #201107293


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
Oral Vitamin D and E alone in men with penile curvature due to PD.
vitamin d2 21st Century Dietary Supplement
oral softgel 2000 IU once daily 9 months
vitamin e GERI-CARE
oral softgels 400 IU and 200 IU 1 softgel of 400 IU daily 1 softgel of 200 IU daily 9 months
(Active Comparator)
Testosterone in combination with oral Vitamin D an E supplementation in men with penile curvature due to PD.
testosterone pellets Testopel 75 mg testosterone pellets
subcutaneous implantation pellets 75 mg based on testosterone levels from resulting bloodwork 9 months

Primary Outcomes

penile curvature
time frame: 9 months

Secondary Outcomes

sexual function
time frame: 9 months

Eligibility Criteria

Male participants from 18 years up to 70 years old.

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

Additional Information

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
Principal investigator Abraham Morgentaler, MD
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Men's Health Boston.