search
Back to results

Safety and Efficacy in Premenopausal Women With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)

Primary Purpose

Heavy Uterine Bleeding, Uterine Fibroids

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Elagolix placebo
Elagolix
0.5 mg estradiol / 0.1 mg norethindrone acetate
1 mg estradiol / 0.5 mg norethindrone acetate
E2/NETA placebo
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heavy Uterine Bleeding focused on measuring Uterine Fibroids, Leiomyomata, Elagolix, Menorrhagia, Elagolix sodium, Heavy Uterine Bleeding, ABT-620

Eligibility Criteria

18 Years - 51 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject is pre-menopausal female 18 to 51 years of age at Screening.
  • Subject has diagnosis of uterine fibroids documented by a Pelvic Ultrasound.
  • Subject has heavy uterine bleeding associated with uterine fibroids.

Exclusion Criteria:

  • Subject has had a myomectomy, uterine artery embolization or high intensity focused ultrasound for fibroid destruction within 6 months prior to Screening or endometrial ablation within 5 years prior to Screening.
  • Subject has a history of osteoporosis or other metabolic bone disease.
  • Subject shows evidence of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric (including depression, schizophrenia, bipolar disorder), or neurologic diseases or any uncontrolled medical illness such as uncontrolled type 2 diabetes. Subject has any history of attempted suicide.
  • Subject has a history of clinically significant condition(s) including but not limited to: * Symptomatic Endometriosis * Epilepsy or seizures * Type 1 diabetes * Chronic kidney disease * Any cancer (except treated basal cell carcinoma of the skin), including breast or ovarian cancer or subject has taken any systemic cancer chemotherapy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm 7

    Arm 8

    Arm Type

    Placebo Comparator

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Experimental

    Experimental

    Experimental

    Arm Label

    Cohort 1: Placebo

    Cohort 1: Elagolix 300 mg BID

    Cohort 1: Elagolix 300 mg BID plus LD E2/NETA QD

    Cohort 1: Elagolix 300 mg BID plus SD E2/NETA QD

    Cohort 2: Placebo

    Cohort 2: Elagolix 600 mg QD

    Cohort 2: Elagolix 600 mg QD plus LD E2/NETA QD

    Cohort 2: Elagolix 600 mg QD plus SD E2/NETA QD

    Arm Description

    Placebo for elagolix and placebo for E2/NETA twice daily (BID)

    Elagolix 300 mg BID alone

    Elagolix 300 mg BID plus low-dose (LD) E2/NETA once daily (QD)

    Elagolix 300 mg BID plus standard-dose (SD) E2/NETA QD

    Placebo for elagolix and E2/NETA QD

    Elagolix 600 mg QD alone

    Elagolix 600 mg QD plus LD E2/NETA QD

    Elagolix 600 mg QD plus SD E2/NETA QD

    Outcomes

    Primary Outcome Measures

    Percentage of Participants With a Menstrual Blood Loss (MBL) Volume of < 80 mL at the Final Month and a ≥ 50% Reduction in MBL Volume From Baseline to the Final Month
    The percentage of participants meeting a composite endpoint consisting of these 2 bleeding assessments: a MBL Volume of < 80 mL at the Final Month and a ≥50% Reduction in MBL Volume from Baseline to the Final Month (last 28 days of treatment). Baseline is defined as the last qualified menstrual cycle during the screening period.

    Secondary Outcome Measures

    Percentage of Participants With a MBL Volume < 80 mL and a ≥ 50% Reduction in MBL Volume From Baseline During the Last 56 to 29 Days of Treatment
    The percentage of participants meeting a composite endpoint consisting of these 2 bleeding assessments: a MBL volume < 80 mL and a ≥ 50% reduction in MBL volume from baseline during the last 56 to 29 days of last treatment. Baseline is defined as the last qualified menstrual cycle during the screening period.
    Percentage of Participants With a MBL Volume < 80 mL and a ≥ 50% Reduction in MBL Volume From Baseline During the Last 84 to 57 Days of Treatment
    The percentage of participants meeting a composite endpoint consisting of these 2 bleeding assessments: a MBL volume < 80 mL and a ≥ 50% reduction in MBL volume from baseline during the last 84 to 57 days of last treatment. Baseline is defined as the last qualified menstrual cycle during the screening period.
    Percentage of Participants Who Achieved an MBL Volume of < 80 mL at the Final Month
    Percentage of participants who achieved an MBL volume of < 80 mL at the Final Month (last 28 days of treatment). Baseline is defined as the last qualified menstrual cycle during the screening period.
    Percentage of Participants With a ≥ 50% Reduction in MBL Volume From Baseline to the Final Month
    Percentage of participants with a >= 50% reduction from baseline in MBL to the Final Month (last 28 days of treatment). Baseline is defined as the last qualified menstrual cycle during the screening period.
    Percentage of Participants Who Achieved Amenorrhea During the Last 56 Days of Treatment
    Amenorrhea is defined as having 0 days of bleeding or spotting based on observed validated and nonvalidated alkaline hematin data and having 0 days of bleeding or spotting, based on imputed electronic diary data during the last 56 days of treatment. Participants needed to have at least 66 days on treatment.
    Percentage of Participants Who Achieved Suppression of Bleeding During the Last 56 Days of Treatment
    Suppression of bleeding is defined as having 0 days of bleeding based on observed validated and nonvalidated alkaline hematin data and having 0 days of bleeding (spotting is allowed) based on imputed electronic diary data during the last 56 days of treatment.
    Mean Change in the Number of Bleeding Days From Baseline to Month 6
    The number of days with any bleeding including spotting was calculated using data collected on daily bleeding diary. Baseline is defined as the last 28 days prior to the first dose day of study drug.
    Mean Change in the Number of Heavy Bleeding Days From Baseline to Month 6
    The number of days with heavy bleeding (either heavy or very heavy/gushing bleeding) was calculated using data collected on daily bleeding diary. Baseline is defined as the last 28 days prior to the first dose day of study drug.
    Change in Bleeding Severity Scores From Baseline at the Final Month
    The average bleeding score was calculated for each 28-day interval starting on Day 29 using data collected on daily bleeding diary using the Mansfield-Voda-Jorgenson (MVJ) Menstrual Bleeding Scale (1=spotting, 2 = very light bleeding, 3 = light bleeding, 4 = moderate bleeding, 5 = heavy bleeding, 6 = very heavy/gushing bleeding). Baseline is defined as the last 28 days prior to the first day of study drug.
    Mean Change in Hemoglobin Concentration From Baseline to Final Visit
    Baseline is defined as the last measurement prior to the first dose of study drug.
    Mean Percentage Change From Baseline in Total Fibroid Volume at Month 3, Month 6, and Final Visit
    Volume of the total fibroid volume (3 largest fibroids), as measured by transvaginal ultrasound, or transabdominal ultrasound.
    Mean Percentage Change From Baseline in Primary Fibroid Volume at Month 3, Month 6, and Final Visit
    Volume of the largest fibroid (primary fibroid), as measured by transvaginal ultrasound, or transabdominal ultrasound.
    Mean Percentage Change From Baseline in Uterine Volume at Month 3, Month 6, and Final Visit
    Uterine volume, as measured by transvaginal ultrasound or transabdominal ultrasound.
    Percentage of Participants With ≥ 25% Reduction From Baseline in Total Fibroid Volume at Month 3, Month 6, and Final Visit
    Total fibroid volume (3 largest fibroids) was measured by transvaginal ultrasound, or transabdominal ultrasound.
    Percentage of Participants With ≥ 25% Reduction From Baseline in Primary Fibroid Volume at Month 3, Month 6, and Final Visit
    Volume of the largest fibroid (primary fibroid) was measured by transvaginal ultrasound or transabdominal ultrasound.
    Percentage of Participants With ≥ 25% Reduction From Baseline in Uterine Volume at Month 3, Month 6, and Final Visit
    Uterine volume was measured by transvaginal ultrasound or transabdominal ultrasound.
    Change From Baseline to Each Month in Non-Bleeding Uterine Fibroids Symptom (NBUFSQ) Questionnaire
    The NBUFSQ (8 items) is a brief patient-reported daily diary that assesses non-bleeding symptoms experienced by women with uterine fibroids. It includes 6 items, asking women to rate their symptoms (abdominal/pelvic pain, pressure, and cramping, back pain, bloating, and urinary problems) in the past 24 hours using an 11-point numeric response scale that ranges from 0 (i.e., no symptom) to 10 (i.e., worst possible symptom) and 2 items to address urinary frequency during the daytime and at night. Data presented in the sum of scores to the 6 symptom questions, ranging from 0 (no symptoms) to 60 (worst possible symptoms). Baseline is defined as the last 28 days prior to the first day of study drug. Final Month is defined as the last 28 days prior to and including the last dose date of study drug.
    Percentage of Participants Who Successfully Avoided Surgical or Invasive Procedures for Uterine Fibroids
    The percentage of participants who successfully avoided surgical or invasive procedures for Uterine Fibroids was assessed.

    Full Information

    First Posted
    March 21, 2013
    Last Updated
    July 7, 2020
    Sponsor
    AbbVie
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01817530
    Brief Title
    Safety and Efficacy in Premenopausal Women With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)
    Official Title
    A Phase 2b Study to Evaluate the Safety and Efficacy of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    April 8, 2013 (Actual)
    Primary Completion Date
    June 2015 (Actual)
    Study Completion Date
    December 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    AbbVie

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is a Phase 2b randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of elagolix alone and in combination with add-back therapy versus placebo on heavy menstrual bleeding in premenopausal women 18 to 51 years of age with uterine fibroids.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heavy Uterine Bleeding, Uterine Fibroids
    Keywords
    Uterine Fibroids, Leiomyomata, Elagolix, Menorrhagia, Elagolix sodium, Heavy Uterine Bleeding, ABT-620

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    571 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cohort 1: Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo for elagolix and placebo for E2/NETA twice daily (BID)
    Arm Title
    Cohort 1: Elagolix 300 mg BID
    Arm Type
    Experimental
    Arm Description
    Elagolix 300 mg BID alone
    Arm Title
    Cohort 1: Elagolix 300 mg BID plus LD E2/NETA QD
    Arm Type
    Experimental
    Arm Description
    Elagolix 300 mg BID plus low-dose (LD) E2/NETA once daily (QD)
    Arm Title
    Cohort 1: Elagolix 300 mg BID plus SD E2/NETA QD
    Arm Type
    Experimental
    Arm Description
    Elagolix 300 mg BID plus standard-dose (SD) E2/NETA QD
    Arm Title
    Cohort 2: Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo for elagolix and E2/NETA QD
    Arm Title
    Cohort 2: Elagolix 600 mg QD
    Arm Type
    Experimental
    Arm Description
    Elagolix 600 mg QD alone
    Arm Title
    Cohort 2: Elagolix 600 mg QD plus LD E2/NETA QD
    Arm Type
    Experimental
    Arm Description
    Elagolix 600 mg QD plus LD E2/NETA QD
    Arm Title
    Cohort 2: Elagolix 600 mg QD plus SD E2/NETA QD
    Arm Type
    Experimental
    Arm Description
    Elagolix 600 mg QD plus SD E2/NETA QD
    Intervention Type
    Other
    Intervention Name(s)
    Elagolix placebo
    Intervention Description
    oral coated tablet
    Intervention Type
    Drug
    Intervention Name(s)
    Elagolix
    Other Intervention Name(s)
    ABT-620
    Intervention Description
    oral coated tablet
    Intervention Type
    Drug
    Intervention Name(s)
    0.5 mg estradiol / 0.1 mg norethindrone acetate
    Other Intervention Name(s)
    Activelle, Activella, low dose (LD) E2/NETA
    Intervention Description
    oral hard capsule
    Intervention Type
    Drug
    Intervention Name(s)
    1 mg estradiol / 0.5 mg norethindrone acetate
    Other Intervention Name(s)
    Activelle, Activella, standard dose (SD) E2/NETA
    Intervention Description
    oral hard capsule
    Intervention Type
    Drug
    Intervention Name(s)
    E2/NETA placebo
    Intervention Description
    oral hard capsule
    Primary Outcome Measure Information:
    Title
    Percentage of Participants With a Menstrual Blood Loss (MBL) Volume of < 80 mL at the Final Month and a ≥ 50% Reduction in MBL Volume From Baseline to the Final Month
    Description
    The percentage of participants meeting a composite endpoint consisting of these 2 bleeding assessments: a MBL Volume of < 80 mL at the Final Month and a ≥50% Reduction in MBL Volume from Baseline to the Final Month (last 28 days of treatment). Baseline is defined as the last qualified menstrual cycle during the screening period.
    Time Frame
    Baseline, Final Month (last 28 days of treatment)
    Secondary Outcome Measure Information:
    Title
    Percentage of Participants With a MBL Volume < 80 mL and a ≥ 50% Reduction in MBL Volume From Baseline During the Last 56 to 29 Days of Treatment
    Description
    The percentage of participants meeting a composite endpoint consisting of these 2 bleeding assessments: a MBL volume < 80 mL and a ≥ 50% reduction in MBL volume from baseline during the last 56 to 29 days of last treatment. Baseline is defined as the last qualified menstrual cycle during the screening period.
    Time Frame
    Baseline, second last 28 days of treatment (last 56 to 29 days of treatment)
    Title
    Percentage of Participants With a MBL Volume < 80 mL and a ≥ 50% Reduction in MBL Volume From Baseline During the Last 84 to 57 Days of Treatment
    Description
    The percentage of participants meeting a composite endpoint consisting of these 2 bleeding assessments: a MBL volume < 80 mL and a ≥ 50% reduction in MBL volume from baseline during the last 84 to 57 days of last treatment. Baseline is defined as the last qualified menstrual cycle during the screening period.
    Time Frame
    Baseline, third last 28 days of treatment (last 84 to 57 days of treatment)
    Title
    Percentage of Participants Who Achieved an MBL Volume of < 80 mL at the Final Month
    Description
    Percentage of participants who achieved an MBL volume of < 80 mL at the Final Month (last 28 days of treatment). Baseline is defined as the last qualified menstrual cycle during the screening period.
    Time Frame
    Final Month (last 28 days of treatment)
    Title
    Percentage of Participants With a ≥ 50% Reduction in MBL Volume From Baseline to the Final Month
    Description
    Percentage of participants with a >= 50% reduction from baseline in MBL to the Final Month (last 28 days of treatment). Baseline is defined as the last qualified menstrual cycle during the screening period.
    Time Frame
    Baseline, Final Month (last 28 days of treatment)
    Title
    Percentage of Participants Who Achieved Amenorrhea During the Last 56 Days of Treatment
    Description
    Amenorrhea is defined as having 0 days of bleeding or spotting based on observed validated and nonvalidated alkaline hematin data and having 0 days of bleeding or spotting, based on imputed electronic diary data during the last 56 days of treatment. Participants needed to have at least 66 days on treatment.
    Time Frame
    Last 56 days of treatment (after 10 days from first dose date)
    Title
    Percentage of Participants Who Achieved Suppression of Bleeding During the Last 56 Days of Treatment
    Description
    Suppression of bleeding is defined as having 0 days of bleeding based on observed validated and nonvalidated alkaline hematin data and having 0 days of bleeding (spotting is allowed) based on imputed electronic diary data during the last 56 days of treatment.
    Time Frame
    Last 56 days of treatment (after 10 days from first dose date)
    Title
    Mean Change in the Number of Bleeding Days From Baseline to Month 6
    Description
    The number of days with any bleeding including spotting was calculated using data collected on daily bleeding diary. Baseline is defined as the last 28 days prior to the first dose day of study drug.
    Time Frame
    Baseline, Month 6
    Title
    Mean Change in the Number of Heavy Bleeding Days From Baseline to Month 6
    Description
    The number of days with heavy bleeding (either heavy or very heavy/gushing bleeding) was calculated using data collected on daily bleeding diary. Baseline is defined as the last 28 days prior to the first dose day of study drug.
    Time Frame
    Baseline, Month 6
    Title
    Change in Bleeding Severity Scores From Baseline at the Final Month
    Description
    The average bleeding score was calculated for each 28-day interval starting on Day 29 using data collected on daily bleeding diary using the Mansfield-Voda-Jorgenson (MVJ) Menstrual Bleeding Scale (1=spotting, 2 = very light bleeding, 3 = light bleeding, 4 = moderate bleeding, 5 = heavy bleeding, 6 = very heavy/gushing bleeding). Baseline is defined as the last 28 days prior to the first day of study drug.
    Time Frame
    Baseline, Final Month (last 28 days of treatment)
    Title
    Mean Change in Hemoglobin Concentration From Baseline to Final Visit
    Description
    Baseline is defined as the last measurement prior to the first dose of study drug.
    Time Frame
    Baseline, Final Visit during treatment period (Month 6 or early termination)
    Title
    Mean Percentage Change From Baseline in Total Fibroid Volume at Month 3, Month 6, and Final Visit
    Description
    Volume of the total fibroid volume (3 largest fibroids), as measured by transvaginal ultrasound, or transabdominal ultrasound.
    Time Frame
    Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination)
    Title
    Mean Percentage Change From Baseline in Primary Fibroid Volume at Month 3, Month 6, and Final Visit
    Description
    Volume of the largest fibroid (primary fibroid), as measured by transvaginal ultrasound, or transabdominal ultrasound.
    Time Frame
    Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination)
    Title
    Mean Percentage Change From Baseline in Uterine Volume at Month 3, Month 6, and Final Visit
    Description
    Uterine volume, as measured by transvaginal ultrasound or transabdominal ultrasound.
    Time Frame
    Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination)
    Title
    Percentage of Participants With ≥ 25% Reduction From Baseline in Total Fibroid Volume at Month 3, Month 6, and Final Visit
    Description
    Total fibroid volume (3 largest fibroids) was measured by transvaginal ultrasound, or transabdominal ultrasound.
    Time Frame
    Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination)
    Title
    Percentage of Participants With ≥ 25% Reduction From Baseline in Primary Fibroid Volume at Month 3, Month 6, and Final Visit
    Description
    Volume of the largest fibroid (primary fibroid) was measured by transvaginal ultrasound or transabdominal ultrasound.
    Time Frame
    Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination)
    Title
    Percentage of Participants With ≥ 25% Reduction From Baseline in Uterine Volume at Month 3, Month 6, and Final Visit
    Description
    Uterine volume was measured by transvaginal ultrasound or transabdominal ultrasound.
    Time Frame
    Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination)
    Title
    Change From Baseline to Each Month in Non-Bleeding Uterine Fibroids Symptom (NBUFSQ) Questionnaire
    Description
    The NBUFSQ (8 items) is a brief patient-reported daily diary that assesses non-bleeding symptoms experienced by women with uterine fibroids. It includes 6 items, asking women to rate their symptoms (abdominal/pelvic pain, pressure, and cramping, back pain, bloating, and urinary problems) in the past 24 hours using an 11-point numeric response scale that ranges from 0 (i.e., no symptom) to 10 (i.e., worst possible symptom) and 2 items to address urinary frequency during the daytime and at night. Data presented in the sum of scores to the 6 symptom questions, ranging from 0 (no symptoms) to 60 (worst possible symptoms). Baseline is defined as the last 28 days prior to the first day of study drug. Final Month is defined as the last 28 days prior to and including the last dose date of study drug.
    Time Frame
    Baseline, Days 1-28, Days 29-56, Days 57-84, Days 85-112, Days 113-140, Days 141-168, Final Month of treatment, Post-treatment (PT) Days 1-28, PT Days 29-56, PT Days 57-84, PT Days 85-112, PT Days 113-140, PT Days 141-168
    Title
    Percentage of Participants Who Successfully Avoided Surgical or Invasive Procedures for Uterine Fibroids
    Description
    The percentage of participants who successfully avoided surgical or invasive procedures for Uterine Fibroids was assessed.
    Time Frame
    Month 6

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    51 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subject is pre-menopausal female 18 to 51 years of age at Screening. Subject has diagnosis of uterine fibroids documented by a Pelvic Ultrasound. Subject has heavy uterine bleeding associated with uterine fibroids. Exclusion Criteria: Subject has had a myomectomy, uterine artery embolization or high intensity focused ultrasound for fibroid destruction within 6 months prior to Screening or endometrial ablation within 5 years prior to Screening. Subject has a history of osteoporosis or other metabolic bone disease. Subject shows evidence of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric (including depression, schizophrenia, bipolar disorder), or neurologic diseases or any uncontrolled medical illness such as uncontrolled type 2 diabetes. Subject has any history of attempted suicide. Subject has a history of clinically significant condition(s) including but not limited to: * Symptomatic Endometriosis * Epilepsy or seizures * Type 1 diabetes * Chronic kidney disease * Any cancer (except treated basal cell carcinoma of the skin), including breast or ovarian cancer or subject has taken any systemic cancer chemotherapy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Charlotte Owens, MD
    Organizational Affiliation
    AbbVie
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan 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 and 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 Sharing Time Frame
    Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
    IPD Sharing 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 (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
    IPD Sharing URL
    https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
    Citations:
    PubMed Identifier
    30303923
    Citation
    Carr BR, Stewart EA, Archer DF, Al-Hendy A, Bradley L, Watts NB, Diamond MP, Gao J, Owens CD, Chwalisz K, Duan WR, Soliman AM, Dufek MB, Simon JA. Elagolix Alone or With Add-Back Therapy in Women With Heavy Menstrual Bleeding and Uterine Leiomyomas: A Randomized Controlled Trial. Obstet Gynecol. 2018 Nov;132(5):1252-1264. doi: 10.1097/AOG.0000000000002933.
    Results Reference
    derived

    Learn more about this trial

    Safety and Efficacy in Premenopausal Women With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)

    We'll reach out to this number within 24 hrs