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

AbbVie

Status and phase: Completed; Phase 2

Conditions: Uterine Fibroids; Heavy Uterine Bleeding

Treatments: Drug: Elagolix; Drug: 0.5 mg estradiol / 0.1 mg norethindrone acetate; Other: Elagolix placebo; Drug: E2/NETA placebo; Drug: 1 mg estradiol / 0.5 mg norethindrone acetate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01817530

2013-000082-37 (EudraCT Number)

M12-813

Details and patient eligibility

About

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.

Enrollment: 571 patients

Sex: Female

Ages: 18 to 51 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

571 participants in 8 patient groups, including a placebo group

Cohort 1: Placebo

Placebo Comparator group

Description:

Placebo for elagolix and placebo for E2/NETA twice daily (BID)

Treatment:

Drug: E2/NETA placebo

Other: Elagolix placebo

Cohort 1: Elagolix 300 mg BID

Experimental group

Description:

Elagolix 300 mg BID alone

Treatment:

Drug: E2/NETA placebo

Drug: Elagolix

Cohort 1: Elagolix 300 mg BID plus LD E2/NETA QD

Experimental group

Description:

Elagolix 300 mg BID plus low-dose (LD) E2/NETA once daily (QD)

Treatment:

Drug: 0.5 mg estradiol / 0.1 mg norethindrone acetate

Drug: Elagolix

Cohort 1: Elagolix 300 mg BID plus SD E2/NETA QD

Experimental group

Description:

Elagolix 300 mg BID plus standard-dose (SD) E2/NETA QD

Treatment:

Drug: 1 mg estradiol / 0.5 mg norethindrone acetate

Drug: Elagolix

Cohort 2: Placebo

Placebo Comparator group

Description:

Placebo for elagolix and E2/NETA QD

Treatment:

Drug: E2/NETA placebo

Other: Elagolix placebo

Cohort 2: Elagolix 600 mg QD

Experimental group

Description:

Elagolix 600 mg QD alone

Treatment:

Drug: E2/NETA placebo

Drug: Elagolix

Cohort 2: Elagolix 600 mg QD plus LD E2/NETA QD

Experimental group

Description:

Elagolix 600 mg QD plus LD E2/NETA QD

Treatment:

Drug: 0.5 mg estradiol / 0.1 mg norethindrone acetate

Drug: Elagolix

Cohort 2: Elagolix 600 mg QD plus SD E2/NETA QD

Experimental group

Description:

Elagolix 600 mg QD plus SD E2/NETA QD

Treatment:

Drug: 1 mg estradiol / 0.5 mg norethindrone acetate

Drug: Elagolix