Long-Term Safety and Efficacy of Elagolix in Combination With Estradiol/ Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women



Status:Recruiting
Conditions:Cervical Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 50
Updated:3/21/2019
Start Date:September 13, 2017
End Date:May 16, 2022
Contact:ABBVIE CALL CENTER
Email:abbvieclinicaltrials@abbvie.com
Phone:847.283.8955

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A Phase 3b Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

This phase 3b study seeks to evaluate the safety and efficacy 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 in the second year.


Inclusion Criteria:

- Participant is a premenopausal female at the time of Screening.

- Participant has a diagnosis of uterine fibroids documented by a Pelvic Ultrasound
[Transabdominal ultrasound (TAU) and transvaginal ultrasound (TVU)].

- Participant has Heavy Menstrual Bleeding (HMB) associated with uterine fibroids as
evidenced by Menstrual Blood Loss (MBL) > 80 mL during each of two screening menses as
measured by the alkaline hematin method.

- Participant has negative urine and/or serum pregnancy test in Washout (if applicable)
and/or Screening and just prior to first dose.

- Participant has an adequate endometrial biopsy performed during Screening, the results
of which show no clinical significant endometrial pathology.

Exclusion Criteria:

- Participant has screening pelvic ultrasound or Saline Infusion Sonohysterography (SIS)
results that show a clinically significant gynecological disorder.

- Participant has history of osteoporosis or other metabolic bone disease.

- Participant has clinically significant abnormalities in clinical chemistry,
hematology, or urinalysis.

- Participant has a history of major depression or post-traumatic stress disorder (PTSD)
episode within 2 years of screening, OR a history of other major psychiatric disorder
at any time (e.g., schizophrenia, bipolar disorder).

- Participant 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 intra-articular injectable (for occasional use) corticosteroids are
allowed.
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