<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/NCT03271489</url>
  </required_header>
  <id_info>
    <org_study_id>M16-283</org_study_id>
    <nct_id>NCT03271489</nct_id>
  </id_info>
  <brief_title>Long-Term Safety Study of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women</brief_title>
  <official_title>A Phase 3b Study to Evaluate the Long-Term Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AbbVie</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AbbVie</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>
      This is phase 3b study seeks to evaluate the safety of elagolix in combination with&#xD;
      estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated&#xD;
      with uterine fibroids in premenopausal women. This study is double-blinded in the first year&#xD;
      and an open-label for the next three years.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 13, 2017</start_date>
  <completion_date type="Anticipated">July 2, 2024</completion_date>
  <primary_completion_date type="Anticipated">November 27, 2023</primary_completion_date>
  <phase>Phase 3</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Bone Mineral Density (BMD)</measure>
    <time_frame>From Baseline through Month 48</time_frame>
    <description>Bone mineral density (BMD) is measured by dual X-ray absorptiometry (DXA).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Heavy Menstrual Bleeding</condition>
  <condition>Uterine Fibroids</condition>
  <arm_group>
    <arm_group_label>Elagolix plus estradiol (E2)/norethindrone acetate (NETA)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Elagolix plus estradiol (E2)/norethindrone acetate (NETA)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Elagolix Placebo</intervention_name>
    <description>Tablets</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>E2/NETA</intervention_name>
    <description>Capsules</description>
    <arm_group_label>Elagolix plus estradiol (E2)/norethindrone acetate (NETA)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>E2/NETA Placebo</intervention_name>
    <description>Capsules</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Elagolix</intervention_name>
    <description>Tablets</description>
    <arm_group_label>Elagolix plus estradiol (E2)/norethindrone acetate (NETA)</arm_group_label>
    <other_name>ABT-620 Elagolix sodium</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant is a premenopausal female at the time of Screening.&#xD;
&#xD;
          -  Participant has a diagnosis of uterine fibroids documented by a Pelvic Ultrasound&#xD;
             [Transabdominal ultrasound (TAU) and transvaginal ultrasound (TVU)].&#xD;
&#xD;
          -  Participant has Heavy Menstrual Bleeding (HMB) associated with uterine fibroids as&#xD;
             evidenced by Menstrual Blood Loss (MBL) &gt; 80 mL during each of two screening menses as&#xD;
             measured by the alkaline hematin method.&#xD;
&#xD;
          -  Participant has negative urine and/or serum pregnancy test during Washout (if&#xD;
             applicable) and/or Screening and just prior to first dose.&#xD;
&#xD;
          -  Participant has an adequate endometrial biopsy performed during Screening, the results&#xD;
             of which show no clinical significant endometrial pathology.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participant has screening pelvic ultrasound or Saline Infusion Sonohysterography (SIS)&#xD;
             results that show a clinically significant gynecological disorder.&#xD;
&#xD;
          -  Participant has history of osteoporosis or other metabolic bone disease.&#xD;
&#xD;
          -  Participant has clinically significant abnormalities in clinical chemistry,&#xD;
             hematology, or urinalysis.&#xD;
&#xD;
          -  Participant has a history of major depression or post-traumatic stress disorder (PTSD)&#xD;
             episode within 2 years of screening, OR a history of other major psychiatric disorder&#xD;
             at any time (e.g., schizophrenia, bipolar disorder).&#xD;
&#xD;
          -  Participant is using any systemic corticosteroids for over 14 days within 3 months&#xD;
             prior to Screening or is likely to require treatment with systemic corticosteroids&#xD;
             during the course of the study. Over the counter and prescription topical, inhaled,&#xD;
             intranasal or intra-articular injectable (for occasional use) corticosteroids are&#xD;
             allowed.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ABBVIE INC.</last_name>
    <role>Study Director</role>
    <affiliation>AbbVie</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Alabama Clinical Therapeutics /ID# 160835</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35235-3430</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alabama Clinical Therapeutics /ID# 160927</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35235-3430</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Choice Research, LLC /ID# 161498</name>
      <address>
        <city>Dothan</city>
        <state>Alabama</state>
        <zip>36303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern Women's Specialists PC /ID# 161531</name>
      <address>
        <city>Fairhope</city>
        <state>Alabama</state>
        <zip>36532-3029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>E Squared Research /ID# 163645</name>
      <address>
        <city>Huntsville</city>
        <state>Alabama</state>
        <zip>35801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Women's Health Alliance of Mobile /ID# 161443</name>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36604-1410</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mobile, OBGYN P.C. /ID# 161530</name>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mesa Obstetricians and Gynecologists /ID# 160955</name>
      <address>
        <city>Mesa</city>
        <state>Arizona</state>
        <zip>85209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Noble Clinical Research /ID# 166949</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vision's Clinical Research-Tucson /ID# 161508</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eclipse Clinical Research /ID# 161516</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85745</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Core Healthcare Group /ID# 160858</name>
      <address>
        <city>Cerritos</city>
        <state>California</state>
        <zip>90703</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diagnamics Inc. /ID# 160950</name>
      <address>
        <city>Encinitas</city>
        <state>California</state>
        <zip>92024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HRC Fertility /ID# 161493</name>
      <address>
        <city>Encino</city>
        <state>California</state>
        <zip>91436</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SC Clinical Research /ID# 164395</name>
      <address>
        <city>Garden Grove</city>
        <state>California</state>
        <zip>92844</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duplicate_Duplicate_Marvel Clinical Research /ID# 167297</name>
      <address>
        <city>Huntington Beach</city>
        <state>California</state>
        <zip>92647</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grossmont Ctr Clin Research /ID# 165120</name>
      <address>
        <city>La Mesa</city>
        <state>California</state>
        <zip>91942</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Olympia Clinical Trials /ID# 201562</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90036-4667</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Research Institute /ID# 160952</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Futura Research, Org /ID# 160924</name>
      <address>
        <city>Montebello</city>
        <state>California</state>
        <zip>90640</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>California Medical Research Associates /ID# 161481</name>
      <address>
        <city>Northridge</city>
        <state>California</state>
        <zip>91324</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northern California Research /ID# 161561</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95821-2640</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Precision Research Institute - San Diego /ID# 163069</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92114-3643</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MD Strategies Research Centers /ID# 161544</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Health care Affiliates Medical Group /ID# 163324</name>
      <address>
        <city>Santa Ana</city>
        <state>California</state>
        <zip>92704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alta California Medical Group /ID# 163564</name>
      <address>
        <city>Simi Valley</city>
        <state>California</state>
        <zip>93065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Upland Clinical Research /ID# 164528</name>
      <address>
        <city>Upland</city>
        <state>California</state>
        <zip>91786-4027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bayview Research Group LLC /ID# 161484</name>
      <address>
        <city>Valley Village</city>
        <state>California</state>
        <zip>91607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced RX Clinical Research /ID# 161599</name>
      <address>
        <city>Westminster</city>
        <state>California</state>
        <zip>92683-4567</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emerson Clinical Research Inst /ID# 162181</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20011</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>James A. Simon, MD, PC /ID# 160931</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20036</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Women's Health Partners /ID# 203577</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33433-7041</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>David Lubetkin MD LLC /ID# 203578</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33486-2269</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brandon Premier Health Care, PA/Gulf Coast Research Group, LLC /ID# 160910</name>
      <address>
        <city>Brandon</city>
        <state>Florida</state>
        <zip>33510-3107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Omega Research Maitland, LLC /ID# 160857</name>
      <address>
        <city>DeBary</city>
        <state>Florida</state>
        <zip>32713-2260</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Midland Florida Clinical Research Center /ID# 161487</name>
      <address>
        <city>DeLand</city>
        <state>Florida</state>
        <zip>32720-0920</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>KO Clinical Research, LLC /ID# 160928</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <zip>33316</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sweet Hope Research Specialty Inc /ID# 163522</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33016-1897</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Solutions Through Adv Rch /ID# 160935</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32256</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Altus Research, Inc /ID# 160912</name>
      <address>
        <city>Lake Worth</city>
        <state>Florida</state>
        <zip>33461</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wellington Anti-Aging Centre /ID# 203540</name>
      <address>
        <city>Loxahatchee Groves</city>
        <state>Florida</state>
        <zip>33470-4937</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Florida Wellness &amp; Clinic /ID# 161535</name>
      <address>
        <city>Margate</city>
        <state>Florida</state>
        <zip>33063</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duplicate_Precision Research Organization /ID# 161522</name>
      <address>
        <city>Miami Lakes</city>
        <state>Florida</state>
        <zip>33016-1501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ocean Blue Medical Research Center, Inc /ID# 161549</name>
      <address>
        <city>Miami Springs</city>
        <state>Florida</state>
        <zip>33166</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Invictus Clinical Research Group,LLC /ID# 160925</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Healthcare Clinical Data, Inc /ID# 160888</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33161</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Palmetto Professional Research /ID# 161442</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33172</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vista Health Research, LLC /ID# 163044</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33176-1032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Salom Tangir, LLC /ID# 162542</name>
      <address>
        <city>Miramar</city>
        <state>Florida</state>
        <zip>33027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Research Institute, Inc /ID# 163748</name>
      <address>
        <city>New Port Richey</city>
        <state>Florida</state>
        <zip>34653</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A Premier Medical Research of FL /ID# 201882</name>
      <address>
        <city>Orange City</city>
        <state>Florida</state>
        <zip>32763-2833</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Associates of Orlando /ID# 160889</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32819-8900</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oncova Clinical Research, Inc. /ID# 160937</name>
      <address>
        <city>Saint Cloud</city>
        <state>Florida</state>
        <zip>34769</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Accel Research Sites - St Petersburg Clinical Research Unit /ID# 160913</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33709-3113</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Physician Care Clin. Res., LLC /ID# 161547</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Treasure Coast Research /ID# 161824</name>
      <address>
        <city>Stuart</city>
        <state>Florida</state>
        <zip>34996</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Discovery Clinical Research /ID# 160891</name>
      <address>
        <city>Sunrise</city>
        <state>Florida</state>
        <zip>33324</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Precision Clinical Research /ID# 165377</name>
      <address>
        <city>Sunrise</city>
        <state>Florida</state>
        <zip>33351-7311</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GCP Clinical Research, LLC /ID# 164593</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33609-4044</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of South Florida /ID# 160960</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jedidiah Clinical Research /ID# 167114</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33617</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virtus Research Consultants, LLC /ID# 160855</name>
      <address>
        <city>Wellington</city>
        <state>Florida</state>
        <zip>33414</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Clinical Trials LLC /ID# 161479</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33409</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Journey Medical Research Insti /ID# 160958</name>
      <address>
        <city>Alpharetta</city>
        <state>Georgia</state>
        <zip>30005</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Paramount Research Solutions /ID# 161557</name>
      <address>
        <city>Alpharetta</city>
        <state>Georgia</state>
        <zip>30005</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Agile Clinical Research Trials /ID# 160941</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30328-5532</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Vernon Clinical Res, LLC /ID# 161491</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30328</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlanta Women's Research Institute /ID# 160844</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30342</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medisense Inc /ID# 161494</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30363</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duplicate_Atlanta Gynecology Research Institute /ID# 160851</name>
      <address>
        <city>Suwanee</city>
        <state>Georgia</state>
        <zip>30024-7159</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bingham Memorial Hospital /ID# 201130</name>
      <address>
        <city>Blackfoot</city>
        <state>Idaho</state>
        <zip>83221</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leavitt Womens Healthcare /ID# 163419</name>
      <address>
        <city>Idaho Falls</city>
        <state>Idaho</state>
        <zip>83404-8322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Womens Healthcare Assoc, DBA /ID# 160933</name>
      <address>
        <city>Idaho Falls</city>
        <state>Idaho</state>
        <zip>83404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sonora Clinical Research /ID# 167610</name>
      <address>
        <city>Meridian</city>
        <state>Idaho</state>
        <zip>83646-1144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asr, Llc /Id# 162179</name>
      <address>
        <city>Nampa</city>
        <state>Idaho</state>
        <zip>83687</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Women's Health Practice, LLC /ID# 161553</name>
      <address>
        <city>Champaign</city>
        <state>Illinois</state>
        <zip>61820</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moore for Women Healthcare and Wellness Institute, LLC /ID# 167118</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60605-2168</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duplicate_University of Chicago /ID# 162667</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Affinity Clinical Research /ID# 160932</name>
      <address>
        <city>Oak Brook</city>
        <state>Illinois</state>
        <zip>60523-1245</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Women's Health Advantage /ID# 161537</name>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
        <zip>46825</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Womens &amp; Family Care, LLC dba /ID# 160890</name>
      <address>
        <city>Shawnee Mission</city>
        <state>Kansas</state>
        <zip>66218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bluegrass Clinical Research /ID# 163485</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40291-1988</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trials Management, LLC - Covington /ID# 160838</name>
      <address>
        <city>Covington</city>
        <state>Louisiana</state>
        <zip>70433</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trials Management, LLC - Covington /ID# 160893</name>
      <address>
        <city>Covington</city>
        <state>Louisiana</state>
        <zip>70433</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praetorian Pharmaceutical Research /ID# 161532</name>
      <address>
        <city>Marrero</city>
        <state>Louisiana</state>
        <zip>70072</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ochsner Baptist Medical Centre /ID# 161507</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Women Under Study, LLC /ID# 163990</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70125-1923</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Willis-Knighton Pediatric GI S /ID# 161534</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exordia Medical Research, Inc /ID# 160853</name>
      <address>
        <city>Fall River</city>
        <state>Massachusetts</state>
        <zip>02723</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Great Lakes Research Group, Inc. /ID# 161511</name>
      <address>
        <city>Bay City</city>
        <state>Michigan</state>
        <zip>48602</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wayne State University /ID# 160944</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201-2013</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valley OB-Gyn Clinic - Saginaw /ID# 203579</name>
      <address>
        <city>Saginaw</city>
        <state>Michigan</state>
        <zip>48602-4323</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saginaw Valley Med Res Group /ID# 160840</name>
      <address>
        <city>Saginaw</city>
        <state>Michigan</state>
        <zip>48604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Quad Clinical Research, LLC /ID# 200943</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Excel Clinical Research /ID# 165588</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Office of Edmond E. Pack, MD /ID# 162604</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89113</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Private practice: Dr. Rex G. Mabey JR /ID# 160915</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jersey Shore University Medical Center /ID# 160916</name>
      <address>
        <city>Neptune</city>
        <state>New Jersey</state>
        <zip>07753-4859</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lovelace Scientific Resources /ID# 163644</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bosque Women's Care /ID# 162606</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SUNY Downstate Medical Center /ID# 160922</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duplicate_Northwell Health System - Manhasset /ID# 201058</name>
      <address>
        <city>Manhasset</city>
        <state>New York</state>
        <zip>11030-3816</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia Univ Medical Center /ID# 161519</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032-3725</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hamburg Regional Gynecology Gr /ID# 161427</name>
      <address>
        <city>Orchard Park</city>
        <state>New York</state>
        <zip>14127</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DJL Clinical Research, PLLC /ID# 161548</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolina Women's Research and Wellness Center /ID# 160914</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27713-7512</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unified Women's Clinical Resea /ID# 163014</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 161490</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unified Women's Clinical Resea /ID# 160957</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Inquest Center Ltd /ID# 160892</name>
      <address>
        <city>Beavercreek</city>
        <state>Ohio</state>
        <zip>45431-2573</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CTI Clinical Research Center /ID# 160942</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univ Hosp Cleveland /ID# 160953</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Ohio Clinical Research /ID# 201162</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43213-3399</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duplicate_Optimed Research /ID# 165600</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hilltop Obstetrics &amp; Gynecology /ID# 203576</name>
      <address>
        <city>Middletown</city>
        <state>Ohio</state>
        <zip>45005-5200</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Toledo /ID# 160923</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43614</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Health and Science University /ID# 161514</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OB/GYN Associates of Erie /ID# 161541</name>
      <address>
        <city>Erie</city>
        <state>Pennsylvania</state>
        <zip>16507-1423</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Penn State University and Milton S. Hershey Medical Center /ID# 160896</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania /ID# 160936</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104-5502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DUP_Thomas Jefferson University /ID# 200304</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vista Clinical Research /ID# 160946</name>
      <address>
        <city>Columbia</city>
        <state>South Carolina</state>
        <zip>29201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VitaLink Research-Spartanburg /ID# 164592</name>
      <address>
        <city>Spartanburg</city>
        <state>South Carolina</state>
        <zip>29303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chattanooga Medical Research /ID# 160885</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>WR-ClinSearch /ID# 160887</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37421-1605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Jackson Clinic, PA /ID# 162496</name>
      <address>
        <city>Jackson</city>
        <state>Tennessee</state>
        <zip>38305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Memphis Associates, LLC /ID# 160939</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38119-3895</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OBGYN North /ID# 203580</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78758-5444</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Austin Area Obstetrics, Gynecology, and Fertility /Id# 203542</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78758-5653</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Discovery Clinical Trials -HCWC /ID# 161543</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75230-2571</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duplicate_The University of Texas Southwestern Medical Center /ID# 161496</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390-8575</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor Scott &amp; White /ID# 161515</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104-4110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Willowbend Health and Wellness - Frisco /ID# 160954</name>
      <address>
        <city>Frisco</city>
        <state>Texas</state>
        <zip>75035</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advances in Health, Inc. /ID# 160930</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ob/Gyn Center /ID# 165928</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Precision Research Institute, LLC /ID# 161554</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77036</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Woman's Hospital of Texas /ID# 160959</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centex Studies, Inc /ID# 163858</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77058-2705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centex Studies, Inc. - Houston /ID# 160917</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77058</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UAG Innovation Women Research, /ID# 167415</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77074</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>America's Adv. Wellness Center /ID# 167548</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77080</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FMC Science /ID# 160886</name>
      <address>
        <city>Lampasas</city>
        <state>Texas</state>
        <zip>76550</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ClinRx Research, LLC /ID# 201170</name>
      <address>
        <city>Plano</city>
        <state>Texas</state>
        <zip>75024-5280</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trials of Texas, Inc /ID# 161510</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VIP Trials /ID# 161546</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Houston Ctr for Clin Research /ID# 160837</name>
      <address>
        <city>Sugar Land</city>
        <state>Texas</state>
        <zip>77479</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Univ Texas HSC at Tyler /ID# 161533</name>
      <address>
        <city>Tyler</city>
        <state>Texas</state>
        <zip>75708</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center of Reproductive Medicine /ID# 162498</name>
      <address>
        <city>Webster</city>
        <state>Texas</state>
        <zip>77598</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univ of Virgnia Medical center /ID# 166283</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908-0816</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eastern Virginia Med School /ID# 160856</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23507-1627</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Partners /ID# 160929</name>
      <address>
        <city>North Chesterfield</city>
        <state>Virginia</state>
        <zip>23235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Partners /ID# 160948</name>
      <address>
        <city>North Chesterfield</city>
        <state>Virginia</state>
        <zip>23235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trials Virginia, Inc. /ID# 160943</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23225</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Specialists for Women /ID# 201129</name>
      <address>
        <city>Suffolk</city>
        <state>Virginia</state>
        <zip>23434-8151</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tidewater Clinical Research /ID# 160949</name>
      <address>
        <city>Virginia Beach</city>
        <state>Virginia</state>
        <zip>23456</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry A. Rodriguez Ginorio, MD /ID# 160861</name>
      <address>
        <city>San Juan</city>
        <zip>00917-5022</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>School of Medicine University of Puerto Rico-Medical Science Campus /ID# 160862</name>
      <address>
        <city>San Juan</city>
        <zip>00935</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Puerto Rico</country>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>February 14, 2023</last_update_submitted>
  <last_update_submitted_qc>February 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Elagolix Sodium</keyword>
  <keyword>Heavy Menstrual Bleeding (HMB)</keyword>
  <keyword>Heavy Uterine Bleeding</keyword>
  <keyword>Leiomyomata</keyword>
  <keyword>Menorrhagia</keyword>
  <keyword>Elagolix + Norethindrone Acetate</keyword>
  <keyword>Elagolix + E2/NETA</keyword>
  <keyword>Elagolix</keyword>
  <keyword>Safety</keyword>
  <keyword>Efficacy</keyword>
  <keyword>ABT-620</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leiomyoma</mesh_term>
    <mesh_term>Myofibroma</mesh_term>
    <mesh_term>Menorrhagia</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/</ipd_time_frame>
    <ipd_access_criteria>Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/</ipd_access_criteria>
    <ipd_url>https://vivli.org/ourmember/abbvie/</ipd_url>
  </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/NCT03271489
org study id: M16-283
nct id: NCT03271489
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This is phase 3b study seeks to evaluate the safety of elagolix in combination with
      estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated
      with uterine fibroids in premenopausal women. This study is double-blinded in the first year
      and an open-label for the next three years.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in Bone Mineral Density (BMD)
time frame: From Baseline through Month 48
description: Bone mineral density (BMD) is measured by dual X-ray absorptiometry (DXA).
arm group label: Elagolix plus estradiol (E2)/norethindrone acetate (NETA)
arm group type: Experimental
description: Elagolix plus estradiol (E2)/norethindrone acetate (NETA)
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo
intervention type: Other
intervention name: Elagolix Placebo
description: Tablets
arm group label: Placebo
intervention type: Drug
intervention name: E2/NETA
description: Capsules
arm group label: Elagolix plus estradiol (E2)/norethindrone acetate (NETA)
intervention type: Other
intervention name: E2/NETA Placebo
description: Capsules
arm group label: Placebo
intervention type: Drug
intervention name: Elagolix
description: Tablets
arm group label: Elagolix plus estradiol (E2)/norethindrone acetate (NETA)
other name: ABT-620 Elagolix sodium
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: ABBVIE INC.
role: Study Director
affiliation: AbbVie
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country: Puerto Rico
country: United States
responsible party type: Sponsor
mesh term: Leiomyoma
mesh term: Myofibroma
mesh term: Menorrhagia
mesh term: Hemorrhage
sharing ipd: Yes
ipd description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
ipd access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
ipd url: https://vivli.org/ourmember/abbvie/