xml: <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/NCT05979389</url>
    </required_header>
    <id_info>
      <org_study_id>23-39274</org_study_id>
      <secondary_id>1R01DK134633-01A1</secondary_id>
      <nct_id>NCT05979389</nct_id>
    </id_info>
    <brief_title>Bicalutamide Therapy in Young Women With NAFLD and PCOS</brief_title>
    <official_title>Pilot Trial of Bicalutamide Versus Placebo in Reproductive-Aged Women With Nonalcoholic Fatty Liver Disease (NAFLD) and Polycystic Ovary Syndrome (PCOS)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of California, San Francisco</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>University of California, San Francisco</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Nonalcoholic steatohepatitis (NASH), or fat-related liver inflammation and scarring is&#xD;
        projected to be the leading cause of cirrhosis in the United States (U.S.) within the next&#xD;
        few years. Women are at disproportionate risk for NASH, with approximately 15 million U.S.&#xD;
        women affected. There is an urgent need to understand risk factors for NASH and its&#xD;
        progression in women, and sex hormones may provide a missing link. This study will study the&#xD;
        contribution of androgens to liver injury and progression in PCOS and mechanistic role of&#xD;
        dysregulated lipid metabolism and visceral adiposity in this process. Such findings will&#xD;
        provide the rationale for future efficacy studies evaluating selective androgen receptor (AR)&#xD;
        antagonism for NASH in PCOS, or alternatively, the need to directly target visceral adiposity&#xD;
        or lipid-specific pathways as part of a precision medicine approach to halt fibrosis&#xD;
        progression in the nearly 5 million young women with PCOS and NAFLD in the U.S., who remain&#xD;
        at increased risk for early onset and progressive liver disease.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a single center, double-blind, placebo-controlled, randomized, (1:1) parallel group&#xD;
        pilot clinical trial of bicalutamide in women with either biopsy-proven or believed NAFLD&#xD;
        receiving 6 months of bicalutamide or placebo. 50 women are targeted for enrollment. Each&#xD;
        participant will be administered a single dose of bicalutamide or placebo once daily for a&#xD;
        total of 6 months. In person evaluations will take place at Month 1, 2, 3, 4, 5, and 6. There&#xD;
        will be a telephone follow up visit within 1 month of end of treatment. This is a pilot&#xD;
        clinical trial that is largely feasibility focused. Study outcomes will include:&#xD;
  &#xD;
          -  Change in liver stiffness on Magnetic Resonance Elastography (MRE)&#xD;
  &#xD;
          -  Change in hepatic steatosis by Magnetic Resonance Proton Density Fat Fraction (PDFF)&#xD;
  &#xD;
          -  Change in visceral adipose tissue (VAT) volume by Magnetic Resonance Imaging (MRI)&#xD;
  &#xD;
          -  Change in NASH histology as assessed by the continuous NAFLD activity score (NAS), which&#xD;
             measures different components of NASH on liver biopsy.&#xD;
  &#xD;
          -  Biochemical endpoints: serum lipids &amp; HOMA-IR&#xD;
  &#xD;
          -  Feasibility outcomes including Rates (and reasons) for the following: a) % women that&#xD;
             decline/women contacted for study inclusion (i.e. concern regarding randomization to&#xD;
             placebo) b) % women enrolled/women screened (i.e. exclusion criteria too narrow), c)&#xD;
             study dropout (i.e. medication side effects, too frequent study visits, and/or&#xD;
             phlebotomy)&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">August 2028</completion_date>
    <primary_completion_date type="Anticipated">August 2028</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>The following treatment regimens will be used:&#xD;
  Experimental treatment - bicalutamide, 50 mg once daily&#xD;
  Placebo or Comparator - one capsule, once daily</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
      <masking_description>Due to the objectives of the study, the identity of test and control treatments will not be known to investigators, research staff, or patients. The following study procedures will be in place to ensure double-blind administration of study treatments Access to the randomization code will be strictly controlled. A color and size-matched placebo capsule that looks identical to the bicalutamide capsule will be used.&#xD;
  Packaging and labeling of test and control treatments will be identical to maintain the blind.&#xD;
  The study blind will be broken on completion of the clinical study, after all study endpoints have been ascertained by blinded study coordinators and after the study database has been locked.&#xD;
  During the study, the blind may be broken only in emergencies when knowledge of the patient's treatment group is necessary for further patient management. The University of California San Francisco investigational pharmacy would then be notified and responsible for unblinding.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Change in liver stiffness on Magnetic Resonance Elastography (MRE)</measure>
      <time_frame>Baseline and 6 months</time_frame>
      <description>The investigators will assess for change in the MRE quantified liver stiffness in kilopascals (kPA)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in hepatic steatosis by Magnetic Resonance Proton Density Fat Fraction (PDFF)</measure>
      <time_frame>Baseline and 6 months</time_frame>
      <description>The investigators will assess for percent change in fat fraction by MRI-PDFF</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in visceral adipose tissue (VAT) volume by Magnetic Resonance Imaging (MRI)</measure>
      <time_frame>Baseline and 6 months</time_frame>
      <description>The investigators will assess for percent change in VAT as quantified by MRI</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change HOMA-IR (Homeostatic model assessment (HOMA) for insulin resistance (IR))</measure>
      <time_frame>Baseline and 6 months</time_frame>
      <description>The investigators will assess change in continuous measures of HOMA-IR as insulin resistance is known to contribute to NASH progression</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in the NAFLD Activity Score (NAS) on a scale from 0 (low activity) to 8 (high activity)</measure>
      <time_frame>Baseline and 6 months</time_frame>
      <description>The investigators will assess for change in this histologic scoring system of NASH as a continuous measure among women willing to undergo end of treatment biopsy (not required).</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>NAFLD</condition>
    <condition>PCOS</condition>
    <arm_group>
      <arm_group_label>Bicalutamide</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>50 mg capsule administered orally once daily for 6 months</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Matching placebo capsule administered orally once daily for 6 months</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Bicalutamide 50 mg</intervention_name>
      <description>Bicalutamide capsules will be prepared from U.S. Pharmacopeia grade powder at a dose of 50 mg</description>
      <arm_group_label>Bicalutamide</arm_group_label>
      <other_name>Casodex</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Matching placebo capsules of the same color, mass, and appearance to the bicalutamide capsules will be filled using microcrystalline cellulose powder.</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Women aged 18-40 years with hyperandrogenic PCOS&#xD;
  &#xD;
            -  NASH identified on liver biopsy or probable NASH on transient elastography- controlled&#xD;
               attenuation parameter (TE-CAP) with cutoffs defined as CAP score ≥270 decibel/m and TE&#xD;
               score &gt; 7.0 kPA or alanine aminotransferase ≥40 U/L).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Uncontrolled diabetes&#xD;
  &#xD;
            -  Alcohol consumption &gt;2 drinks per day for at least 3 consecutive months over the&#xD;
               previous 5 years&#xD;
  &#xD;
            -  Other chronic liver disease (i.e. hepatitis B virus, hepatitis C virus, autoimmune&#xD;
               hepatitis) or cirrhosis from any cause&#xD;
  &#xD;
            -  Recent or planned upcoming weight reduction surgery within five years of diagnosis of&#xD;
               biopsy-confirmed NASH&#xD;
  &#xD;
            -  HIV infection&#xD;
  &#xD;
            -  Drugs associated with fatty liver (i.e. amiodarone, methotrexate, systemic&#xD;
               glucocorticoids, tamoxifen, anabolic steroids, valproic acid) for more than 4 weeks&#xD;
               prior to baseline or during study&#xD;
  &#xD;
            -  Recent, current, or planned upcoming pregnancy or current perimenopausal status&#xD;
  &#xD;
            -  Renal impairment (glomerular filtration rate &lt;45 ml/min/1.73m or potassium levels &gt;&#xD;
               5.0 mmol/L)&#xD;
  &#xD;
            -  Androgen receptor antagonist use (i.e. spironolactone or flutamide) for more than 3&#xD;
               months within one year prior to baseline&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Monika A Sarkar, MD, MAS</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of California, San Francisco</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Elle K Oberweis-Manion</last_name>
      <phone>(415)-502-3725</phone>
      <email>elle.oberweismanion@ucsf.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of California San Francisco</name>
        <address>
          <city>San Francisco</city>
          <state>California</state>
          <zip>94143</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Monika A Sarkar, MD</last_name>
        <phone>415-502-2656</phone>
        <email>monika.sarkar@ucsf.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Maldonado SS, Grab J, Wang CW, Huddleston H, Cedars M, Sarkar M. Polycystic ovary syndrome is associated with nonalcoholic steatohepatitis in women of reproductive age. Hepatol Commun. 2022 Oct;6(10):2634-2639. doi: 10.1002/hep4.2039. Epub 2022 Jul 21.</citation>
      <PMID>35861548</PMID>
    </reference>
    <reference>
      <citation>Sarkar MA, Suzuki A, Abdelmalek MF, Yates KP, Wilson LA, Bass NM, Gill R, Cedars M, Terrault N; NASH Clinical Research Network. Testosterone is Associated With Nonalcoholic Steatohepatitis and Fibrosis in Premenopausal Women With NAFLD. Clin Gastroenterol Hepatol. 2021 Jun;19(6):1267-1274.e1. doi: 10.1016/j.cgh.2020.09.045. Epub 2020 Oct 1.</citation>
      <PMID>33010412</PMID>
    </reference>
    <reference>
      <citation>Sanchez-Garrido MA, Tena-Sempere M. Metabolic dysfunction in polycystic ovary syndrome: Pathogenic role of androgen excess and potential therapeutic strategies. Mol Metab. 2020 May;35:100937. doi: 10.1016/j.molmet.2020.01.001. Epub 2020 Feb 5.</citation>
      <PMID>32244180</PMID>
    </reference>
    <reference>
      <citation>O'Reilly MW, Kempegowda P, Walsh M, Taylor AE, Manolopoulos KN, Allwood JW, Semple RK, Hebenstreit D, Dunn WB, Tomlinson JW, Arlt W. AKR1C3-Mediated Adipose Androgen Generation Drives Lipotoxicity in Women With Polycystic Ovary Syndrome. J Clin Endocrinol Metab. 2017 Sep 1;102(9):3327-3339. doi: 10.1210/jc.2017-00947.</citation>
      <PMID>28645211</PMID>
    </reference>
    <reference>
      <citation>Dieudonne MN, Pecquery R, Boumediene A, Leneveu MC, Giudicelli Y. Androgen receptors in human preadipocytes and adipocytes: regional specificities and regulation by sex steroids. Am J Physiol. 1998 Jun;274(6):C1645-52. doi: 10.1152/ajpcell.1998.274.6.C1645.</citation>
      <PMID>9611130</PMID>
    </reference>
    <reference>
      <citation>Gambineri A, Patton L, Vaccina A, Cacciari M, Morselli-Labate AM, Cavazza C, Pagotto U, Pasquali R. Treatment with flutamide, metformin, and their combination added to a hypocaloric diet in overweight-obese women with polycystic ovary syndrome: a randomized, 12-month, placebo-controlled study. J Clin Endocrinol Metab. 2006 Oct;91(10):3970-80. doi: 10.1210/jc.2005-2250. Epub 2006 Jul 25.</citation>
      <PMID>16868063</PMID>
    </reference>
    <reference>
      <citation>Cusi K. Role of obesity and lipotoxicity in the development of nonalcoholic steatohepatitis: pathophysiology and clinical implications. Gastroenterology. 2012 Apr;142(4):711-725.e6. doi: 10.1053/j.gastro.2012.02.003. Epub 2012 Feb 8.</citation>
      <PMID>22326434</PMID>
    </reference>
    <reference>
      <citation>Macut D, Tziomalos K, Bozic-Antic I, Bjekic-Macut J, Katsikis I, Papadakis E, Andric Z, Panidis D. Non-alcoholic fatty liver disease is associated with insulin resistance and lipid accumulation product in women with polycystic ovary syndrome. Hum Reprod. 2016 Jun;31(6):1347-53. doi: 10.1093/humrep/dew076. Epub 2016 Apr 12.</citation>
      <PMID>27076501</PMID>
    </reference>
    <reference>
      <citation>Kumarendran B, O'Reilly MW, Manolopoulos KN, Toulis KA, Gokhale KM, Sitch AJ, Wijeyaratne CN, Coomarasamy A, Arlt W, Nirantharakumar K. Polycystic ovary syndrome, androgen excess, and the risk of nonalcoholic fatty liver disease in women: A longitudinal study based on a United Kingdom primary care database. PLoS Med. 2018 Mar 28;15(3):e1002542. doi: 10.1371/journal.pmed.1002542. eCollection 2018 Mar.</citation>
      <PMID>29590099</PMID>
    </reference>
    <reference>
      <citation>Ismail FF, Meah N, Trindade de Carvalho L, Bhoyrul B, Wall D, Sinclair R. Safety of oral bicalutamide in female pattern hair loss: A retrospective review of 316 patients. J Am Acad Dermatol. 2020 Nov;83(5):1478-1479. doi: 10.1016/j.jaad.2020.03.034. Epub 2020 Mar 22. No abstract available.</citation>
      <PMID>32213304</PMID>
    </reference>
    <reference>
      <citation>Fernandez-Nieto D, Saceda-Corralo D, Rodrigues-Barata R, Hermosa-Gelbard A, Moreno-Arrones O, Jimenez-Cauhe J, Ortega-Quijano D, Vano-Galvan S. Oral bicalutamide for female pattern hair loss: A pilot study. Dermatol Ther. 2019 Nov;32(6):e13096. doi: 10.1111/dth.13096. Epub 2019 Oct 10. No abstract available.</citation>
      <PMID>31579984</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Non-alcoholic Fatty Liver Disease</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Bicalutamide</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05979389
  org study id: 23-39274
  secondary id: 1R01DK134633-01A1
  nct id: NCT05979389
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  Nonalcoholic steatohepatitis (NASH), or fat-related liver inflammation and scarring is
        projected to be the leading cause of cirrhosis in the United States (U.S.) within the next
        few years. Women are at disproportionate risk for NASH, with approximately 15 million U.S.
        women affected. There is an urgent need to understand risk factors for NASH and its
        progression in women, and sex hormones may provide a missing link. This study will study the
        contribution of androgens to liver injury and progression in PCOS and mechanistic role of
        dysregulated lipid metabolism and visceral adiposity in this process. Such findings will
        provide the rationale for future efficacy studies evaluating selective androgen receptor (AR)
        antagonism for NASH in PCOS, or alternatively, the need to directly target visceral adiposity
        or lipid-specific pathways as part of a precision medicine approach to halt fibrosis
        progression in the nearly 5 million young women with PCOS and NAFLD in the U.S., who remain
        at increased risk for early onset and progressive liver disease.
  This is a single center, double-blind, placebo-controlled, randomized, (1:1) parallel group
        pilot clinical trial of bicalutamide in women with either biopsy-proven or believed NAFLD
        receiving 6 months of bicalutamide or placebo. 50 women are targeted for enrollment. Each
        participant will be administered a single dose of bicalutamide or placebo once daily for a
        total of 6 months. In person evaluations will take place at Month 1, 2, 3, 4, 5, and 6. There
        will be a telephone follow up visit within 1 month of end of treatment. This is a pilot
        clinical trial that is largely feasibility focused. Study outcomes will include:
  
          -  Change in liver stiffness on Magnetic Resonance Elastography (MRE)
  
          -  Change in hepatic steatosis by Magnetic Resonance Proton Density Fat Fraction (PDFF)
  
          -  Change in visceral adipose tissue (VAT) volume by Magnetic Resonance Imaging (MRI)
  
          -  Change in NASH histology as assessed by the continuous NAFLD activity score (NAS), which
             measures different components of NASH on liver biopsy.
  
          -  Biochemical endpoints: serum lipids & HOMA-IR
  
          -  Feasibility outcomes including Rates (and reasons) for the following: a) % women that
             decline/women contacted for study inclusion (i.e. concern regarding randomization to
             placebo) b) % women enrolled/women screened (i.e. exclusion criteria too narrow), c)
             study dropout (i.e. medication side effects, too frequent study visits, and/or
             phlebotomy)
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: The following treatment regimens will be used:
  Experimental treatment - bicalutamide, 50 mg once daily
  Placebo or Comparator - one capsule, once daily
  primary purpose: Other
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  masking description: Due to the objectives of the study, the identity of test and control treatments will not be known to investigators, research staff, or patients. The following study procedures will be in place to ensure double-blind administration of study treatments Access to the randomization code will be strictly controlled. A color and size-matched placebo capsule that looks identical to the bicalutamide capsule will be used.
  Packaging and labeling of test and control treatments will be identical to maintain the blind.
  The study blind will be broken on completion of the clinical study, after all study endpoints have been ascertained by blinded study coordinators and after the study database has been locked.
  During the study, the blind may be broken only in emergencies when knowledge of the patient's treatment group is necessary for further patient management. The University of California San Francisco investigational pharmacy would then be notified and responsible for unblinding.
  measure: Change in liver stiffness on Magnetic Resonance Elastography (MRE)
  time frame: Baseline and 6 months
  description: The investigators will assess for change in the MRE quantified liver stiffness in kilopascals (kPA)
  measure: Change in hepatic steatosis by Magnetic Resonance Proton Density Fat Fraction (PDFF)
  time frame: Baseline and 6 months
  description: The investigators will assess for percent change in fat fraction by MRI-PDFF
  measure: Change in visceral adipose tissue (VAT) volume by Magnetic Resonance Imaging (MRI)
  time frame: Baseline and 6 months
  description: The investigators will assess for percent change in VAT as quantified by MRI
  measure: Change HOMA-IR (Homeostatic model assessment (HOMA) for insulin resistance (IR))
  time frame: Baseline and 6 months
  description: The investigators will assess change in continuous measures of HOMA-IR as insulin resistance is known to contribute to NASH progression
  measure: Change in the NAFLD Activity Score (NAS) on a scale from 0 (low activity) to 8 (high activity)
  time frame: Baseline and 6 months
  description: The investigators will assess for change in this histologic scoring system of NASH as a continuous measure among women willing to undergo end of treatment biopsy (not required).
  arm group label: Bicalutamide
  arm group type: Experimental
  description: 50 mg capsule administered orally once daily for 6 months
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Matching placebo capsule administered orally once daily for 6 months
  intervention type: Drug
  intervention name: Bicalutamide 50 mg
  description: Bicalutamide capsules will be prepared from U.S. Pharmacopeia grade powder at a dose of 50 mg
  arm group label: Bicalutamide
  other name: Casodex
  intervention type: Drug
  intervention name: Placebo
  description: Matching placebo capsules of the same color, mass, and appearance to the bicalutamide capsules will be filled using microcrystalline cellulose powder.
  arm group label: Placebo
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 40 Years
  healthy volunteers: No
  last name: Monika A Sarkar, MD, MAS
  role: Principal Investigator
  affiliation: University of California, San Francisco
  last name: Elle K Oberweis-Manion
  phone: (415)-502-3725
  email: elle.oberweismanion@ucsf.edu
  facility: 
  contact: 
  country: United States
  citation: Maldonado SS, Grab J, Wang CW, Huddleston H, Cedars M, Sarkar M. Polycystic ovary syndrome is associated with nonalcoholic steatohepatitis in women of reproductive age. Hepatol Commun. 2022 Oct;6(10):2634-2639. doi: 10.1002/hep4.2039. Epub 2022 Jul 21.
  PMID: 35861548
  citation: Sarkar MA, Suzuki A, Abdelmalek MF, Yates KP, Wilson LA, Bass NM, Gill R, Cedars M, Terrault N; NASH Clinical Research Network. Testosterone is Associated With Nonalcoholic Steatohepatitis and Fibrosis in Premenopausal Women With NAFLD. Clin Gastroenterol Hepatol. 2021 Jun;19(6):1267-1274.e1. doi: 10.1016/j.cgh.2020.09.045. Epub 2020 Oct 1.
  PMID: 33010412
  citation: Sanchez-Garrido MA, Tena-Sempere M. Metabolic dysfunction in polycystic ovary syndrome: Pathogenic role of androgen excess and potential therapeutic strategies. Mol Metab. 2020 May;35:100937. doi: 10.1016/j.molmet.2020.01.001. Epub 2020 Feb 5.
  PMID: 32244180
  citation: O'Reilly MW, Kempegowda P, Walsh M, Taylor AE, Manolopoulos KN, Allwood JW, Semple RK, Hebenstreit D, Dunn WB, Tomlinson JW, Arlt W. AKR1C3-Mediated Adipose Androgen Generation Drives Lipotoxicity in Women With Polycystic Ovary Syndrome. J Clin Endocrinol Metab. 2017 Sep 1;102(9):3327-3339. doi: 10.1210/jc.2017-00947.
  PMID: 28645211
  citation: Dieudonne MN, Pecquery R, Boumediene A, Leneveu MC, Giudicelli Y. Androgen receptors in human preadipocytes and adipocytes: regional specificities and regulation by sex steroids. Am J Physiol. 1998 Jun;274(6):C1645-52. doi: 10.1152/ajpcell.1998.274.6.C1645.
  PMID: 9611130
  citation: Gambineri A, Patton L, Vaccina A, Cacciari M, Morselli-Labate AM, Cavazza C, Pagotto U, Pasquali R. Treatment with flutamide, metformin, and their combination added to a hypocaloric diet in overweight-obese women with polycystic ovary syndrome: a randomized, 12-month, placebo-controlled study. J Clin Endocrinol Metab. 2006 Oct;91(10):3970-80. doi: 10.1210/jc.2005-2250. Epub 2006 Jul 25.
  PMID: 16868063
  citation: Cusi K. Role of obesity and lipotoxicity in the development of nonalcoholic steatohepatitis: pathophysiology and clinical implications. Gastroenterology. 2012 Apr;142(4):711-725.e6. doi: 10.1053/j.gastro.2012.02.003. Epub 2012 Feb 8.
  PMID: 22326434
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  responsible party type: Sponsor
  mesh term: Non-alcoholic Fatty Liver Disease
  mesh term: Bicalutamide
  sharing ipd: No