<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03815331</url>
  </required_header>
  <id_info>
    <org_study_id>MHB024</org_study_id>
    <nct_id>NCT03815331</nct_id>
  </id_info>
  <brief_title>Xiaflex® Plus Testosterone Treatment Pilot Study Protocol</brief_title>
  <official_title>Xiaflex® Plus Testosterone Treatment Pilot Study Protocol A Six-month, Pilot Project of Testosterone Treatment in Subjects Who Are Undergoing Xiaflex® Therapy for the Treatment of Peyronie's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Men's Health Boston</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Men's Health Boston</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this open-label, six-month, pilot study of men with Peyronie's disease there will be one&#xD;
      subject group consisting of 20 subjects. All subjects will receive Xiaflex® plus testosterone&#xD;
      (T) treatment (Aveed®). Males included in the study must be 18-70 years old; have a history&#xD;
      of PD for more than six months; and have at two serum total testosterone level less than 350&#xD;
      ng/dL within 30 days prior to enrollment. The primary objective of this pilot study is to&#xD;
      determine whether testosterone therapy offers increased efficacy of Xiaflex® (collagenase&#xD;
      clostridium histolyticum) in subjects undergoing treatment for Peyronie's disease.&#xD;
&#xD;
      Endpoints will include reduction in degree of curvature and response to the PDQ&#xD;
      questionnaire. Secondary objectives will be to assess men for change in plaque size, quality&#xD;
      of life parameters, and sexual function. Data collected from this pilot study will be&#xD;
      analyzed and compared to historical data regarding treatment for PD using Xiaflex® only. This&#xD;
      pilot study will establish preliminary evidence needed to continue more in-depth research&#xD;
      regarding Xiaflex® with T therapy and serve as a means to evaluate feasibility of a&#xD;
      full-scale study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      During this single-center pilot study, there will be one subject group consisting of men with&#xD;
      Peyronie's disease and testosterone deficiency. Subject age range will be 18-70 years. Each&#xD;
      subject will participate for approximately 6 months. All 20 subjects will receive Xiaflex®&#xD;
      plus T treatment (Aveed®). Data collected from this pilot project will be analyzed and&#xD;
      compared to historical data regarding treatment for PD using Xiaflex® only.&#xD;
&#xD;
      The eligibility criterion for 2 samples of total testosterone (&lt;350ng/dL) or free&#xD;
      testosterone (1.5 ng/dL analog assay or 100pg/mL calculated free testosterone) was chosen&#xD;
      with the aim of demonstrating what the effect of testosterone treatment is on men that fall&#xD;
      into the low range. The remainder of the inclusion and exclusion criteria are designed to&#xD;
      select subjects for whom protocol treatment is considered appropriate. All relevant medical&#xD;
      and non-medical conditions will be taken into consideration when deciding whether this&#xD;
      protocol is suitable for a particular subject.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 14, 2019</start_date>
  <completion_date type="Actual">December 30, 2020</completion_date>
  <primary_completion_date type="Actual">December 29, 2020</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <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.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change in penile curvature</measure>
    <time_frame>6 months</time_frame>
    <description>The primary objective of this study is to determine whether supplemental testosterone treatment offers change in efficacy to Xiaflex® (collagenase clostridium histolyticum) alone in selected men undergoing treatment for Peyronie's disease. The primary endpoints are change in degrees of penile curvature from baseline.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in PDQ responses</measure>
    <time_frame>6 months</time_frame>
    <description>change in global sexual satisfaction, as measured by the Peyronie's Disease Questionnaire (PDQ).&#xD;
Not a scale but direct comparison of patients sexual activity through patients' answers.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in plaque size</measure>
    <time_frame>6 months</time_frame>
    <description>(mm longest diameter)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life</measure>
    <time_frame>6 months</time_frame>
    <description>(Patient Health Questionnaire) Scale total can range from 0 to 27 (Not difficult at all to very difficult) Higher values would be worse outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of erections and satisfaction with sexual function</measure>
    <time_frame>6 months</time_frame>
    <description>(International Index of Erectile Function) No scale, direct comparison of answers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life</measure>
    <time_frame>6 months</time_frame>
    <description>(Low T Questionnaire) Scale total ranges from 0 to 84 (strongly agree to strongly disagree) Higher values would be worse outcome</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Peyronie's Disease (PD)</condition>
  <arm_group>
    <arm_group_label>PD treatment with Xiaflex® plus Aveed</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Peyronie's Disease treatment with Xiaflex® and Aveed®. All 20 subjects will be treated with Xiaflex® and Aveed®. The data collected from this pilot project will be analyzed and compared to historical data regarding treatment for PD with Xiaflex® alone.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Xiaflex®</intervention_name>
    <description>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</description>
    <arm_group_label>PD treatment with Xiaflex® plus Aveed</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aveed</intervention_name>
    <description>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.</description>
    <arm_group_label>PD treatment with Xiaflex® plus Aveed</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Ability to read, write, and understand English&#xD;
&#xD;
          2. Age greater than or equal to 18&#xD;
&#xD;
          3. Age less than or equal to 70&#xD;
&#xD;
          4. Identification of acquired penile curvature of greater than 30 degrees and less than&#xD;
             90 degrees associated with palpable penile plaque on physical examination at screening&#xD;
&#xD;
          5. Screening total testosterone of less than 350 ng/dL, twice withine 30 days of&#xD;
             treatment&#xD;
&#xD;
          6. Screening free testosterone of less than 1.5ng/dL (analog assay) or 100pg/mL&#xD;
             (calculated)&#xD;
&#xD;
          7. Planning to initiate Xiaflex® injections at MHB&#xD;
&#xD;
          8. Willingness to initiate testosterone therapy&#xD;
&#xD;
          9. Willing to be followed at MHB for the next 3 months&#xD;
&#xD;
         10. Willing to provide informed consent for this study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Prior history of treatment for PD that includes surgery&#xD;
&#xD;
          2. Prior treatment with oral therapy for PD unless at least stopped 2 weeks prior to&#xD;
             signing the informed consent (e.g. Potaba, Vitamin E, colchicines)&#xD;
&#xD;
          3. Previous exposure to exogenous T, clomiphene citrate, or other Selective Estrogen&#xD;
             Receptor Modulators, unless off therapy for at least 12 weeks&#xD;
&#xD;
          4. Presence of dense calcified plaque by ultrasound at screening&#xD;
&#xD;
          5. Hypersensitivity to testosterone, stearic acid, or polyvinylpyrolidone (the&#xD;
             constituents of Aveed®)&#xD;
&#xD;
          6. Unwillingness to start testosterone therapy&#xD;
&#xD;
          7. Screening total testosterone of greater than 350 ng/dL&#xD;
&#xD;
          8. Screening free testosterone of more than 1.5ng/dL (analog assay) or 100pg/mL&#xD;
             (calculated)&#xD;
&#xD;
          9. Unable to achieve adequate erection with penile injection to assess degree of&#xD;
             curvature&#xD;
&#xD;
         10. Prior history of definitive treatment for prostate cancer, bladder cancer, or other&#xD;
             pelvic malignancies including surgery, external beam radiation therapy, brachytherapy,&#xD;
             cryotherapy&#xD;
&#xD;
         11. Prior history of prostate cancer, hematologic disorders, chronic liver disease&#xD;
             including cirrhosis and hepatitis C, disorders affecting the immune system, including&#xD;
             infection with human immunodeficiency virus, or psychiatric disorders including major&#xD;
             depression, schizophrenia, bipolar disease&#xD;
&#xD;
         12. Prior history of cerebrovascular accident, history of deep venous thrombosis within&#xD;
             the past 5 years or history of untreated or severe sleep apnea&#xD;
&#xD;
         13. Screening PSA more than 4.0 ng/mL, unless prostate cancer has been excluded to the&#xD;
             Investigator's satisfaction&#xD;
&#xD;
         14. Incapable of giving informed consent or complying with the protocol&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Abraham Morgentaler, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Men's Health Boston</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Men's Health Boston</name>
      <address>
        <city>Chestnut Hill</city>
        <state>Massachusetts</state>
        <zip>02467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Brock G, Hsu GL, Nunes L, von Heyden B, Lue TF. The anatomy of the tunica albuginea in the normal penis and Peyronie's disease. J Urol. 1997 Jan;157(1):276-81.</citation>
    <PMID>8976279</PMID>
  </reference>
  <reference>
    <citation>Moreno SA, Morgentaler A. Testosterone deficiency and Peyronie's disease: pilot data suggesting a significant relationship. J Sex Med. 2009 Jun;6(6):1729-1735. doi: 10.1111/j.1743-6109.2009.01250.x. Epub 2009 Mar 30.</citation>
    <PMID>19473459</PMID>
  </reference>
  <reference>
    <citation>Gonzalez-Cadavid NF, Magee TR, Ferrini M, Qian A, Vernet D, Rajfer J. Gene expression in Peyronie's disease. Int J Impot Res. 2002 Oct;14(5):361-74. doi: 10.1038/sj.ijir.3900873.</citation>
    <PMID>12454687</PMID>
  </reference>
  <reference>
    <citation>Devine CJ Jr, Somers KD, Jordan SG, Schlossberg SM. Proposal: trauma as the cause of the Peyronie's lesion. J Urol. 1997 Jan;157(1):285-90. doi: 10.1016/s0022-5347(01)65361-8.</citation>
    <PMID>8976281</PMID>
  </reference>
  <reference>
    <citation>Shen ZJ, Zhou XL, Lu YL, Chen ZD. Effect of androgen deprivation on penile ultrastructure. Asian J Androl. 2003 Mar;5(1):33-6.</citation>
    <PMID>12647000</PMID>
  </reference>
  <reference>
    <citation>Demling RH. The role of anabolic hormones for wound healing in catabolic states. J Burns Wounds. 2005 Jan 17;4:e2.</citation>
    <PMID>16921407</PMID>
  </reference>
  <reference>
    <citation>Hetzler LE, Sharma N, Tanzer L, Wurster RD, Leonetti J, Marzo SJ, Jones KJ, Foecking EM. Accelerating functional recovery after rat facial nerve injury: Effects of gonadal steroids and electrical stimulation. Otolaryngol Head Neck Surg. 2008 Jul;139(1):62-7. doi: 10.1016/j.otohns.2008.02.006.</citation>
    <PMID>18585563</PMID>
  </reference>
  <reference>
    <citation>Maus U, Andereya S, Schmidt H, Zombory G, Gravius S, Ohnsorge JA, Niedhart C. [Therapy effects of testosterone on the recovery of bone defects]. Z Orthop Unfall. 2008 Jan-Feb;146(1):59-63. doi: 10.1055/s-2007-989436. German.</citation>
    <PMID>18324583</PMID>
  </reference>
  <reference>
    <citation>Cavallini G, Biagiotti G, Lo Giudice C. Association between Peyronie disease and low serum testosterone levels: detection and therapeutic considerations. J Androl. 2012 May-Jun;33(3):381-8. doi: 10.2164/jandrol.111.012948. Epub 2011 Jun 30.</citation>
    <PMID>21719695</PMID>
  </reference>
  <reference>
    <citation>Stallard N. Optimal sample sizes for phase II clinical trials and pilot studies. Stat Med. 2012 May 20;31(11-12):1031-42. doi: 10.1002/sim.4357. Epub 2011 Nov 3.</citation>
    <PMID>22052407</PMID>
  </reference>
  <results_reference>
    <citation>Taylor FL, Levine LA. Peyronie's Disease. Urol Clin North Am. 2007 Nov;34(4):517-34, vi. doi: 10.1016/j.ucl.2007.08.017.</citation>
    <PMID>17983892</PMID>
  </results_reference>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>December 30, 2020</last_update_submitted>
  <last_update_submitted_qc>December 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Men's Health Boston</investigator_affiliation>
    <investigator_full_name>Dr. Abraham Morgentaler</investigator_full_name>
    <investigator_title>PI/MD</investigator_title>
  </responsible_party>
  <keyword>Peyronie's disease</keyword>
  <keyword>Hypogonadism</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Penile Induration</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03815331
org study id: MHB024
nct id: NCT03815331
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
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.
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.
allocation: N/A
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.
primary purpose: Treatment
masking: None (Open Label)
measure: change in penile curvature
time frame: 6 months
description: The primary objective of this study is to determine whether supplemental testosterone treatment offers change in efficacy to Xiaflex® (collagenase clostridium histolyticum) alone in selected men undergoing treatment for Peyronie's disease. The primary endpoints are change in degrees of penile curvature from baseline.
measure: change in PDQ responses
time frame: 6 months
description: change in global sexual satisfaction, as measured by the Peyronie's Disease Questionnaire (PDQ).
Not a scale but direct comparison of patients sexual activity through patients' answers.
measure: Change in plaque size
time frame: 6 months
description: (mm longest diameter)
measure: Change in quality of life
time frame: 6 months
description: (Patient Health Questionnaire) Scale total can range from 0 to 27 (Not difficult at all to very difficult) Higher values would be worse outcome
measure: Quality of erections and satisfaction with sexual function
time frame: 6 months
description: (International Index of Erectile Function) No scale, direct comparison of answers
measure: Change in quality of life
time frame: 6 months
description: (Low T Questionnaire) Scale total ranges from 0 to 84 (strongly agree to strongly disagree) Higher values would be worse outcome
arm group label: PD treatment with Xiaflex® plus Aveed
arm group type: Experimental
description: Peyronie's Disease treatment with Xiaflex® and Aveed®. All 20 subjects will be treated with Xiaflex® and Aveed®. The data collected from this pilot project will be analyzed and compared to historical data regarding treatment for PD with Xiaflex® alone.
intervention type: Drug
intervention name: Xiaflex®
description: 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
arm group label: PD treatment with Xiaflex® plus Aveed
intervention type: Drug
intervention name: Aveed
description: 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.
arm group label: PD treatment with Xiaflex® plus Aveed
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Abraham Morgentaler, MD
role: Principal Investigator
affiliation: Men's Health Boston
facility: 
country: United States
citation: Brock G, Hsu GL, Nunes L, von Heyden B, Lue TF. The anatomy of the tunica albuginea in the normal penis and Peyronie's disease. J Urol. 1997 Jan;157(1):276-81.
PMID: 8976279
citation: Moreno SA, Morgentaler A. Testosterone deficiency and Peyronie's disease: pilot data suggesting a significant relationship. J Sex Med. 2009 Jun;6(6):1729-1735. doi: 10.1111/j.1743-6109.2009.01250.x. Epub 2009 Mar 30.
PMID: 19473459
citation: Gonzalez-Cadavid NF, Magee TR, Ferrini M, Qian A, Vernet D, Rajfer J. Gene expression in Peyronie's disease. Int J Impot Res. 2002 Oct;14(5):361-74. doi: 10.1038/sj.ijir.3900873.
PMID: 12454687
citation: Devine CJ Jr, Somers KD, Jordan SG, Schlossberg SM. Proposal: trauma as the cause of the Peyronie's lesion. J Urol. 1997 Jan;157(1):285-90. doi: 10.1016/s0022-5347(01)65361-8.
PMID: 8976281
citation: Shen ZJ, Zhou XL, Lu YL, Chen ZD. Effect of androgen deprivation on penile ultrastructure. Asian J Androl. 2003 Mar;5(1):33-6.
PMID: 12647000
citation: Demling RH. The role of anabolic hormones for wound healing in catabolic states. J Burns Wounds. 2005 Jan 17;4:e2.
PMID: 16921407
citation: Hetzler LE, Sharma N, Tanzer L, Wurster RD, Leonetti J, Marzo SJ, Jones KJ, Foecking EM. Accelerating functional recovery after rat facial nerve injury: Effects of gonadal steroids and electrical stimulation. Otolaryngol Head Neck Surg. 2008 Jul;139(1):62-7. doi: 10.1016/j.otohns.2008.02.006.
PMID: 18585563
citation: Maus U, Andereya S, Schmidt H, Zombory G, Gravius S, Ohnsorge JA, Niedhart C. [Therapy effects of testosterone on the recovery of bone defects]. Z Orthop Unfall. 2008 Jan-Feb;146(1):59-63. doi: 10.1055/s-2007-989436. German.
PMID: 18324583
citation: Cavallini G, Biagiotti G, Lo Giudice C. Association between Peyronie disease and low serum testosterone levels: detection and therapeutic considerations. J Androl. 2012 May-Jun;33(3):381-8. doi: 10.2164/jandrol.111.012948. Epub 2011 Jun 30.
PMID: 21719695
citation: Stallard N. Optimal sample sizes for phase II clinical trials and pilot studies. Stat Med. 2012 May 20;31(11-12):1031-42. doi: 10.1002/sim.4357. Epub 2011 Nov 3.
PMID: 22052407
citation: Taylor FL, Levine LA. Peyronie's Disease. Urol Clin North Am. 2007 Nov;34(4):517-34, vi. doi: 10.1016/j.ucl.2007.08.017.
PMID: 17983892
responsible party type: Principal Investigator
investigator affiliation: Men's Health Boston
investigator full name: Dr. Abraham Morgentaler
investigator title: PI/MD
mesh term: Penile Induration
sharing ipd: Undecided