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

AbbVie

Status and phase: Completed; Phase 3

Conditions: Uterine Fibroids; Heavy Menstrual Bleeding

Treatments: Drug: Placebo for Elagolix; Drug: Placebo for Estradiol/Norethindrone Acetate; Drug: Elagolix; Drug: Estradiol/Norethindrone Acetate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02654054

M12-815

Details and patient eligibility

About

This study seeks to evaluate the efficacy, safety and tolerability of elagolix alone and in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.

Enrollment: 413 patients

Sex: Female

Ages: 18 to 51 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject is a premenopausal female at the time of Screening.
• Subject has a diagnosis of uterine fibroids documented by a pelvic ultrasound (transabdominal ultrasound/transvaginal ultrasound).
• Subject has heavy menstrual bleeding associated with uterine fibroids as evidenced by menstrual blood loss > 80 mL during each of two screening menses as measured by the alkaline hematin method.
• Subject has negative urine and/or serum pregnancy test in Screening and just prior to first dose.
• Subject has an adequate endometrial biopsy performed during Screening, the results of which show no clinically significant endometrial pathology.

Exclusion criteria

• Subject has screening pelvic ultrasound or saline infusion sonohysterography results that show a clinically significant gynecological disorder.
• Subject has history of osteoporosis or other metabolic bone disease.
• Subject has clinically significant abnormalities in clinical chemistry, hematology, or urinalysis.
• Subject has a history of major depression or post-traumatic stress disorder (PTSD) within 2 years of screening, OR a history of other major psychiatric disorder at any time (e.g., schizophrenia, bipolar disorder).
• Subject 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 injectable (for occasional use) corticosteroids are allowed.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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413 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo for both elagolix twice daily (BID) and norethindrone acetate (E2/NETA) once daily (QD)

Treatment:

Drug: Placebo for Elagolix

Drug: Placebo for Estradiol/Norethindrone Acetate

Elagolix

Experimental group

Description:

Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD

Treatment:

Drug: Elagolix

Drug: Placebo for Estradiol/Norethindrone Acetate

Elagolix + E2/NETA

Experimental group

Description:

Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD

Treatment:

Drug: Estradiol/Norethindrone Acetate

Drug: Elagolix