Xiaflex® Plus Testosterone Treatment Pilot Study Protocol

During this single-center pilot study, there will be one subject group consisting of men with Peyronie's disease and testosterone deficiency. Subject age range will be 18-70 years. Each subject will participate for approximately 6 months. All 20 subjects will receive Xiaflex® plus T treatment (Aveed®). Data collected from this pilot project will be analyzed and compared to historical data regarding treatment for PD using Xiaflex® only.

The eligibility criterion for 2 samples of total testosterone (<350ng/dL) or free testosterone (1.5 ng/dL analog assay or 100pg/mL calculated free testosterone) was chosen with the aim of demonstrating what the effect of testosterone treatment is on men that fall into the low range. The remainder of the inclusion and exclusion criteria are designed to select subjects for whom protocol treatment is considered appropriate. All relevant medical and non-medical conditions will be taken into consideration when deciding whether this protocol is suitable for a particular subject.

Inclusion criteria

• Ability to read, write, and understand English
• Age greater than or equal to 18
• Age less than or equal to 70
• Identification of acquired penile curvature of greater than 30 degrees and less than 90 degrees associated with palpable penile plaque on physical examination at screening
• Screening total testosterone of less than 350 ng/dL, twice withine 30 days of treatment
• Screening free testosterone of less than 1.5ng/dL (analog assay) or 100pg/mL (calculated)
• Planning to initiate Xiaflex® injections at MHB
• Willingness to initiate testosterone therapy
• Willing to be followed at MHB for the next 3 months
• Willing to provide informed consent for this study

Exclusion criteria

• Prior history of treatment for PD that includes surgery
• Prior treatment with oral therapy for PD unless at least stopped 2 weeks prior to signing the informed consent (e.g. Potaba, Vitamin E, colchicines)
• Previous exposure to exogenous T, clomiphene citrate, or other Selective Estrogen Receptor Modulators, unless off therapy for at least 12 weeks
• Presence of dense calcified plaque by ultrasound at screening
• Hypersensitivity to testosterone, stearic acid, or polyvinylpyrolidone (the constituents of Aveed®)
• Unwillingness to start testosterone therapy
• Screening total testosterone of greater than 350 ng/dL
• Screening free testosterone of more than 1.5ng/dL (analog assay) or 100pg/mL (calculated)
• Unable to achieve adequate erection with penile injection to assess degree of curvature
• Prior history of 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
• Prior history of cerebrovascular accident, history of deep venous thrombosis within the past 5 years or history of untreated or severe sleep apnea
• Screening PSA more than 4.0 ng/mL, unless prostate cancer has been excluded to the Investigator's satisfaction
• Incapable of giving informed consent or complying with the protocol