Safety and Efficacy in Premenopausal Women With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)

Study Identifier
M12-813
CT.gov Identifier
NCT01817530
EudraCT Identifier
2013-000082-37
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
Download document(s)

Study Details

Medical Condition
  • Uterine Fibroids
    • Study Drug
  • Elagolix
  • 0.5 mg estradiol / 0.1 mg norethindrone acetate
  • 1 mg estradiol / 0.5 mg norethindrone acetate
  • E2/NETA placebo
    • Phase
    Phase 2
    Sex
    Female
    Age
    18 - 51 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Subject is pre-menopausal female 18 to 51 years of age at Screening. * Subject has diagnosis of uterine fibroids documented by a Pelvic Ultrasound. * Subject has heavy uterine bleeding associated with uterine fibroids.
    Exclusion Criteria:
    * Subject has had a myomectomy, uterine artery embolization or high intensity focused ultrasound for fibroid destruction within 6 months prior to Screening or endometrial ablation within 5 years prior to Screening. * 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, schizophrenia, bipolar disorder), or neurologic diseases or any uncontrolled medical illness such as uncontrolled type 2 diabetes. Subject has any history of attempted suicide. * Subject has a history of clinically significant condition(s) including but not limited to: \* Symptomatic Endometriosis \* Epilepsy or seizures \* Type 1 diabetes \* Chronic kidney disease \* Any cancer (except treated basal cell carcinoma of the skin), including breast or ovarian cancer or subject has taken any systemic cancer chemotherapy

    Protocol Summary

    This is a Phase 2b randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of elagolix alone and in combination with add-back therapy versus placebo on heavy menstrual bleeding in premenopausal women 18 to 51 years of age with uterine fibroids.

    Study Locations

    No locations found.