Summary:
Phase 3b, sequential, randomized, 1-year double-blind placebocontrolled,
1-year open-label, multi-center study is designed to
evaluate the long term safety and efficacy of elagolix with add back
therapy in women with heavy menstrual bleeding associated with
uterine fibroids in premenopausal women 18 to 48 years of age
Key Inclusion Criteria:
- Subject is a premenopausal female 18 to 48 years of age at the time of Screening.
- Subject has a diagnosis of uterine fibroids documented by a Pelvic Ultrasound (TAU, TVU) assessed by a central reader and verification that a uterine fibroid meets at least one of the following criteria:
o Intramural, submucosal non-pedunculated fibroid with a diameter ≥ 2 cm (longest
diameter).
o Subserosal fibroid ≥ 4 cm.
o Multiple fibroids with a total uterine volume of ≥ 200 cm3 to ≤ 2,500 cm3.
- 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 2 Screening FSH levels of < 30 mIU/mL (30 IU/L) within at least 1 week apart prior to randomization.
- Subject has a negative urine and/or serum pregnancy test(s) during the Washout (if applicable) and/or Screening Periods, and has a negative urine pregnancy test just prior to first dose.
- Subject must agree to use two forms of non-hormonal contraception (dual contraception) consistently during the Washout (if applicable), Screening and Treatment Periods. Acceptable methods of dual contraception include the following combinations:
o Condom with spermicide (foam, gel or polymer film).
o Diaphragm with spermicide (condom may or may not be used).
o Cervical cap with spermicide (condom may or may not be used).
Subject is not required to use dual contraception methods if:
o Sexual partner(s) is vasectomized, at least 6 months prior to Screening.
o Subject practices total abstinence from sexual intercourse, as the preferred lifestyle of the subject; periodic abstinence is not acceptable.
o Subject had a bilateral tubal occlusion or tubal ligation at least 4 months prior to Screening.
o Subject is not sexually active with men; periodic sexual relationship(s) with men requires the use of dual non-hormonal contraception as noted above.
- Subject has an adequate endometrial biopsy performed during Screening, the results of which show no clinically significant endometrial pathology.