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ClinicalTrials.gov Identifier: NCT02691494

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)

    Status Completed
    Related Conditions
    Uterine Fibroids
    Heavy Menstrual Bleeding

Enrollment Details

385 Worldwide Enrollment Goal

Study Type:  Interventional

This is a type  phase trial.

Protocol ID
M12-817

Brief summary

Top

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

Participant Attributes :
  • Female
  • Ages 18 Years to 51 Years

Canada: 2

0
Sudbury, ON
1
Windsor, ON
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Study Design

  • The method used to assign participants to an arm of a clinical trial, for example Randomized (assigned by chance) versus Non-randomized.
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    Allocation

    Randomized

  • A target outcome that the study’s protocol aims to evaluate - things like: the occurrence of a disease, a symptom, sign, or lab abnormality, among others.
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    Endpoint Classification

    Safety/Efficacy Study

  • The general design that shows how the medical interventions will be assigned to the participants, e.g., whether all patients will receive the same drug, or if different groups receive two or more different treatments in a particular order.
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    Intervention Model

    Parallel Assignment

  • The general design that describes the strategy for identifying and following up with participants during observational studies.
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    Masking

    Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

  • This is the single main reason for carrying out the clinical trial. Reasons can include: treatment, prevention, diagnostic advances, supportive care, screening, or health services research, among others.
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    Purpose

    Treatment

    • Subject is a premenopausal female at the time of Screening.
    • Subject has a diagnosis of uterine fibroids documented by a Pelvic Ultrasound (TAU, TVU).
    • Subject has HMB associated with uterine fibroids as evidenced by MBL > 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.
    • Subject has screening pelvic ultrasound or SIS 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.