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Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women (Replicate Study)

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ClinicalTrials.gov Identifier: NCT02691494
Recruitment Status : Completed
First Posted : February 25, 2016
Results First Posted : June 30, 2020
Last Update Posted : July 21, 2020
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE February 22, 2016
First Posted Date  ICMJE February 25, 2016
Results First Submitted Date  ICMJE June 12, 2020
Results First Posted Date  ICMJE June 30, 2020
Last Update Posted Date July 21, 2020
Actual Study Start Date  ICMJE February 3, 2016
Actual Primary Completion Date February 14, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2020)
Percentage of Participants Meeting the Criteria for Responder [ Time Frame: Final Month (the last 28 days prior to and including the Reference Day), up to Month 6 ]
Percentage of responders, defined as participants who met the following conditions:
  • Menstrual blood loss (MBL) volume < 80 mL during the Final Month (the last 28 days prior to and including the Reference Day, which is defined as the last visit date during the Treatment Period (last treatment visit date) or the last dose date if there are evaluable alkaline hematin data after the last treatment visit date and prior to or on the last dose date), and
  • ≥ 50% reduction in MBL volume from Baseline to the Final Month.
Participants who prematurely discontinued study drug due to "lack of efficacy," "requires surgery or invasive intervention for treatment of uterine fibroids," or "adverse events" were considered non-responders regardless of whether she meets the two aforementioned responder criteria or not.
Original Primary Outcome Measures  ICMJE
 (submitted: February 22, 2016)
Percentage of Responders based on menstrual blood loss (MBL) volume reduction at Final Month [ Time Frame: From Baseline to Final Month of Treatment Period (up through 6 months) ]
Assessed using alkaline hematin methodology
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2020)
  • Change From Baseline in MBL Volume to the Final Month [ Time Frame: Baseline and Final Month (the last 28 days prior to and including the Reference Day), up to Month 6 ]
    Baseline MBL volume was defined as the mean of total MBL volume from all the qualified menstrual cycles during the Screening Period, in which the total MBL volume is from all validated and non-validated sanitary products and the MBL volume of validated sanitary products only (excluding non-validated sanitary products) was greater than 80 mL. The Reference Day is defined as the last visit date during the Treatment Period (last treatment visit date) or the last dose date if there are evaluable alkaline hematin data after the last treatment visit date and prior to or on the last dose date.
  • Percentage of Participants With Suppression of Bleeding at the Final Month [ Time Frame: Final Month (the last 28 days prior to and including the Reference Day), up to Month 6 ]
    Suppression of bleeding is defined as having 0 days of bleeding (spotting is allowed) during the Final Month with the interval starting from Study Day 11. The Reference Day is defined as the last visit date during the Treatment Period (last treatment visit date) or the last dose date if there are evaluable alkaline hematin data after the last treatment visit date and prior to or on the last dose date.
  • Change From Baseline in MBL Volume to Month 6 [ Time Frame: Month 0 (Baseline), Month 6 ]
    Baseline MBL volume was defined as the mean of total MBL volume from all the qualified menstrual cycles during the Screening Period, in which the total MBL volume is from all validated and non-validated sanitary products and the MBL volume of validated sanitary products only (excluding non-validated sanitary products) was greater than 80 mL.
  • Change From Baseline in MBL Volume to Month 3 [ Time Frame: Month 0 (Baseline), Month 3 ]
    Baseline MBL volume was defined as the mean of total MBL volume from all the qualified menstrual cycles during the Screening Period, in which the total MBL volume is from all validated and non-validated sanitary products and the MBL volume of validated sanitary products only (excluding non-validated sanitary products) was greater than 80 mL.
  • Percentage of Participants With Baseline Hemoglobin <= 10.5 g/dL Who Have an Increase in Hemoglobin > 2 g/dL at Month 6 [ Time Frame: Month 0 (Baseline), Month 6 ]
  • Change From Baseline in MBL Volume to Month 1 [ Time Frame: Month 0 (Baseline), Month 1 ]
    Baseline MBL volume was defined as the mean of total MBL volume from all the qualified menstrual cycles during the Screening Period, in which the total MBL volume is from all validated and non-validated sanitary products and the MBL volume of validated sanitary products only (excluding non-validated sanitary products) was greater than 80 mL.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 22, 2016)
  • Change in MBL volume [ Time Frame: From Month 0 (Baseline) to Final Month (the last 28 days of treatment) ]
  • Monthly Change in MBL Volume [ Time Frame: From Month 0 (Baseline) to Month 6 ]
  • Percentage of Subjects with Suppression of Bleeding [ Time Frame: During 6-Month Treatment Period ]
  • Percentage of Subjects with Increase in Hemoglobin [ Time Frame: From Month 0 (Baseline) to Month 6 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women (Replicate Study)
Official Title  ICMJE A Phase 3 Study to Evaluate the Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
Brief Summary This study seeks to evaluate the efficacy, safety and tolerability of elagolix alone and in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Uterine Fibroids
  • Heavy Menstrual Bleeding
Intervention  ICMJE
  • Drug: Elagolix
    Film-coated tablets
    Other Names:
    • ABT-620
    • elagolix sodium
  • Drug: Placebo for Estradiol/Norethindrone Acetate
    Placebo capsules
  • Drug: Estradiol/Norethindrone Acetate
    Commercially-available E2/NETA tablets were over-encapsulated to maintain study blinding.
    Other Name: E2/NETA
  • Drug: Placebo for Elagolix
    Film-coated placebo tablets
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo for both elagolix twice daily (BID) and norethindrone acetate (E2/ NETA) once daily (QD)
    Interventions:
    • Drug: Placebo for Estradiol/Norethindrone Acetate
    • Drug: Placebo for Elagolix
  • Experimental: Elagolix
    Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
    Interventions:
    • Drug: Elagolix
    • Drug: Placebo for Estradiol/Norethindrone Acetate
  • Experimental: Elagolix + E2/NETA
    Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
    Interventions:
    • Drug: Elagolix
    • Drug: Estradiol/Norethindrone Acetate
Publications * Schlaff WD, Ackerman RT, Al-Hendy A, Archer DF, Barnhart KT, Bradley LD, Carr BR, Feinberg EC, Hurtado SM, Kim J, Liu R, Mabey RG Jr, Owens CD, Poindexter A, Puscheck EE, Rodriguez-Ginorio H, Simon JA, Soliman AM, Stewart EA, Watts NB, Muneyyirci-Delale O. Elagolix for Heavy Menstrual Bleeding in Women with Uterine Fibroids. N Engl J Med. 2020 Jan 23;382(4):328-340. doi: 10.1056/NEJMoa1904351.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 26, 2018)
378
Original Estimated Enrollment  ICMJE
 (submitted: February 22, 2016)
400
Actual Study Completion Date  ICMJE January 23, 2019
Actual Primary Completion Date February 14, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject is a premenopausal female at the time of Screening.
  • Subject has a diagnosis of uterine fibroids documented by a pelvic ultrasound (transabdominal ultrasound/transvaginal ultrasound).
  • Subject has heavy menstrual bleeding associated with uterine fibroids as evidenced by menstrual blood loss > 80 mL during each of two screening menses as measured by the alkaline hematin method.
  • Subject has negative urine and/or serum pregnancy test in Screening and just prior to first dose.
  • Subject has an adequate endometrial biopsy performed during Screening, the results of which show no clinically significant endometrial pathology.

Exclusion Criteria:

  • Subject has screening pelvic ultrasound or saline infusion sonohysterography results that show a clinically significant gynecological disorder.
  • Subject has history of osteoporosis or other metabolic bone disease.
  • Subject has clinically significant abnormalities in clinical chemistry, hematology, or urinalysis.
  • Subject has a history of major depression or post-traumatic stress disorder (PTSD) within 2 years of screening, OR a history of other major psychiatric disorder at any time (e.g., schizophrenia, bipolar disorder).
  • Subject is using any systemic corticosteroids for over 14 days within 3 months prior to Screening or is likely to require treatment with systemic corticosteroids during the course of the study. Over the counter and prescription topical, inhaled, intranasal or injectable (for occasional use) corticosteroids are allowed.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 51 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02691494
Other Study ID Numbers  ICMJE M12-817
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP