An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

AbbVie

Status and phase: Completed; Phase 3

Conditions: Uterine Fibroids; Heavy Menstrual Bleeding

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02925494

M12-816

Details and patient eligibility

About

This is an extension study for women who have already received six months of treatment in the phase III clinical trial M12-815 (NCT02654054) or M12-817 (NCT02691494), and will evaluate the long-term efficacy and safety of elagolix administered alone and in combination with estradiol/norethindrone acetate for an additional six months in the treatment of heavy menstrual bleeding associated with uterine fibroids.

Enrollment: 433 patients

Sex: Female

Ages: 18 to 51 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant has completed the 6-Month Treatment Period of their respective Pivotal Study (either Study M12-815 or Study M12-817).
• Participant did not meet removal criteria in bone mineral density (BMD) decrease in the spine, total hip and femoral neck at Month 6 of the Treatment Period of their respective Pivotal Study
• Participant has negative urine and/or serum pregnancy test(s) results were consistently negative during the Treatment Period of their respective Pivotal Study and prior to first dose in this study.
• Participant's endometrial biopsy from the Month 6 Visit of their respective Pivotal Study shows no clinically significant endometrial pathology.

Exclusion criteria

• Participant met criteria for removal from therapy in her respective Pivotal Study.
• Participant is planning a pregnancy within the next 18 months.
• Participant has current suicidal markers as noted at the Month 6 visit of her respective pivotal study.
• Participant has any new medical conditions that may be unsuitable for participation.
• Participant is using any systemic corticosteroids for over 14 days 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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433 participants in 2 patient groups

Elagolix plus Estradiol/Norethindrone Acetate (E2/NETA)

Experimental group

Description:

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

Treatment:

Drug: Estradiol/Norethindrone Acetate

Drug: Elagolix

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