An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02925494
Recruitment Status : Active, not recruiting
First Posted : October 6, 2016
Last Update Posted : February 15, 2019
Information provided by (Responsible Party):

Brief Summary:
This is an extension study for women who have already received six months of treatment in the phase III clinical trial M12-815 or M12-817, and will evaluate the long-term efficacy and safety of elagolix administered alone and in combination with estradiol/norethindrone acetate for an additional six months in the treatment of heavy menstrual bleeding associated with uterine fibroids.

Condition or disease Intervention/treatment Phase
Uterine Fibroids Heavy Menstrual Bleeding Drug: Estradiol/Norethindrone Acetate Drug: Elagolix Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 433 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
Actual Study Start Date : September 14, 2016
Actual Primary Completion Date : May 7, 2018
Estimated Study Completion Date : March 29, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Elagolix plus Estradiol/Norethindrone Acetate (E2/NETA)
Participants receiving Elagolix plus E2/NETA
Drug: Estradiol/Norethindrone Acetate
Oral administration

Drug: Elagolix
Oral administration
Other Names:
  • ABT-620
  • Elagolix Sodium

Experimental: Elagolix
Participants receiving Elagolix
Drug: Elagolix
Oral administration
Other Names:
  • ABT-620
  • Elagolix Sodium

Primary Outcome Measures :
  1. Percentage of Responders based on menstrual blood loss volume reduction [ Time Frame: From Month 0 (Baseline in Pivotal Study) to Final Month of Treatment Period (up through 12 months) ]
    Assessed using alkaline hematin methodology.

Secondary Outcome Measures :
  1. Change in Menstrual Blood Loss (MBL) Volume [ Time Frame: From Month 0 to Final Month (last 28 days of treatment) ]
    Assessed using alkaline hematin methodology

  2. Percentage of participants with increase in Hemoglobin [ Time Frame: Month 0 to Month 6 ]
    This assesses the concentration of hemoglobin.

  3. Percentage of participants with suppression of bleeding [ Time Frame: Up to Month 6 (during 6-Month treatment period) ]
    Suppression of bleeding is defined as having no days of bleeding (spotting is allowed) during a 28-day interval.

  4. Change in MBL Volume by Month [ Time Frame: Every Month From Month 0 (Baseline) through Month 6 ]
    Assessed using alkaline hematin methodology

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 51 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Participant has completed the 6-Month Treatment Period of their respective Pivotal Study (either Study M12-815 or Study M12-817).
  • Participant did not meet removal criteria in bone mineral density (BMD) decrease in the spine, total hip and femoral neck at Month 6 of the Treatment Period of their respective Pivotal Study
  • Participant has negative urine and/or serum pregnancy test(s) results were consistently negative during the Treatment Period of their respective Pivotal Study and prior to first dose in this study.
  • Participant's endometrial biopsy from the Month 6 Visit of their respective Pivotal Study shows no clinically significant endometrial pathology.

Exclusion Criteria:

  • Participant met criteria for removal from therapy in her respective Pivotal Study.
  • Participant is planning a pregnancy within the next 18 months.
  • Participant has current suicidal markers as noted at the Month 6 visit of her respective pivotal study.
  • Participant has any new medical conditions that may be unsuitable for participation.
  • Participant is using any systemic corticosteroids for over 14 days 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02925494

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Sponsors and Collaborators
Study Director: AbbVie Inc. AbbVie

Responsible Party: AbbVie Identifier: NCT02925494     History of Changes
Other Study ID Numbers: M12-816
First Posted: October 6, 2016    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
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.

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

Keywords provided by AbbVie:
Uterine Fibroids
Heavy Menstrual Bleeding
Elagolix Sodium
Elagolix plus Norethindrone Acetate

Additional relevant MeSH terms:
Pathologic Processes
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Connective Tissue Diseases
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Menstruation Disturbances
Polyestradiol phosphate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Norethindrone acetate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic