Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids
Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids
The purpose of this proof-of-concept study is to assess the safety and effectiveness of
 elagolix versus placebo to reduce uterine bleeding associated with uterine fibroids, and to
 reduce fibroid volume and uterine volume in premenopausal women 20 to 49 years of age with
 heavy uterine bleeding.
Inclusion Criteria:

 -  Subject is a pre-menopausal female 20 to 49 years of age.

 -  Subject has a diagnosis of uterine fibroids documented by a pelvic ultrasound assessed
 by a central reader and verification that a fibroid present met the following
 criteria:

 -  At least 1 fibroid with diameter ≥ 2 cm (longest diameter), or multiple small
 fibroids with a total uterine volume of ≥ 200 cm³ to ≤ 2,500 cm³ (approximately
 22 weeks' gestation) as documented by a centrally read ultrasound.

 -  Only intramural, submucosal non-pedunculated, and subserosal fibroids qualified
 subjects for enrollment (intracavitary pedunculated fibroids were exclusionary).

 -  Ultrasound procedures were performed during the Screening Period, and subjects
 were not randomized until the investigator reviewed the central reader results
 verifying the inclusion requirements.

 -  Subject has a history of regular menstrual cycles between 24 to 35 days.

 -  Subject has heavy uterine bleeding associated with uterine fibroids as evidenced by
 blood loss > 80 mL during 2 screening menstrual cycles, measured by the alkaline
 hematin method.

 Exclusion Criteria:

 -  Subject has had a myomectomy, uterine artery embolization, or high intensity focused
 ultrasound for fibroid destruction within 1 year prior to randomization or any history
 of endometrial ablation.

 -  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), or neurologic diseases or any uncontrolled medical illness such as
 uncontrolled type 2 diabetes.

 -  Subject has a history of clinically significant condition(s) including but not limited
 to:

 -  Endometriosis

 -  Epilepsy or seizures

 -  Type 1 diabetes

 -  Any cancer (except basal cell carcinoma of the skin), including breast or ovarian
 cancer or subject has taken any systemic cancer chemotherapy