Xiaflex® Plus Testosterone Treatment Pilot Study Protocol
Condition: Peyronie's Disease (PD)
MeSH terms: Penile Induration
Study type: Interventional
Phase: Phase 4

Summary: 
      In this open-label, six-month, pilot study of men with Peyronie's disease there will be one
      subject group consisting of 20 subjects. All subjects will receive Xiaflex® plus testosterone
      (T) treatment (Aveed®). Males included in the study must be 18-70 years old; have a history
      of PD for more than six months; and have at two serum total testosterone level less than 350
      ng/dL within 30 days prior to enrollment. The primary objective of this pilot study is to
      determine whether testosterone therapy offers increased efficacy of Xiaflex® (collagenase
      clostridium histolyticum) in subjects undergoing treatment for Peyronie's disease.

      Endpoints will include reduction in degree of curvature and response to the PDQ
      questionnaire. Secondary objectives will be to assess men for change in plaque size, quality
      of life parameters, and sexual function. Data collected from this pilot study will be
      analyzed and compared to historical data regarding treatment for PD using Xiaflex® only. This
      pilot study will establish preliminary evidence needed to continue more in-depth research
      regarding Xiaflex® with T therapy and serve as a means to evaluate feasibility of a
      full-scale study.
    

Detailed description: 
      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.
    

Intervention name(s): Xiaflex®; Aveed
Intervention type(s): Drug; Drug
Intervention description(s): medication indicated for the treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy. Xiaflex belongs to a family of enzymes called collagenases. Collagenases are proteinases that hydrolyze collagen in its native triple helical conformation under physiological conditions, resulting in lysis of collagen deposits. The signs and symptoms of Peyronie's disease are caused by a collagen plaque. Injection of XIAFLEX into a Peyronie's plaque, which is comprised mostly of collagen, may result in enzymatic disruption of the plaque. Following this disruption of the plaque, penile curvature deformity and patient bother caused by Peyronie's disease are reduced; Aveed® is an FDA-approved medication for treatment of hypogonadism (low testosterone). It is not approved for the treatment of Peyronie's Disease. Aveed® 750 mg/3mL injection will be placed intramuscularly at the beginning of study, at four weeks, at 10 weeks thereafter.
Intervention model: Single Group Assignment
Intervention model description: 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.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Peyronie's disease; Hypogonadism