Placebo for Estradiol/Norethindrone Acetate

DRUG2 trials

Sponsors

AbbVie

Conditions

Heavy Menstrual BleedingUterine Fibroids

Phase 3

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

CompletedNCT02654054

AbbVieHeavy Menstrual Bleeding, Uterine Fibroids

Start: 2015-12-22End: 2018-12-12Updated: 2020-06-29

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 (Replicate Study)

CompletedNCT02691494

AbbVieHeavy Menstrual Bleeding, Uterine Fibroids

Start: 2016-02-03End: 2019-01-23Updated: 2021-07-13

Related Papers

Impact of demographic and clinical factors on elagolix plus add-back therapy effects on patient-reported nonbleeding symptoms in women with heavy menstrual bleeding and uterine fibroids: a post hoc analysis of data from two clinical trials

F&S Reports2024-06-151 citations

Elagolix With Add-Back Therapy Improves Hemoglobin Concentration in Women With Fibroid-Associated Heavy Menstrual Bleeding Across Subgroups: Post Hoc Analysis of Elaris UF-1 and UF-2 [ID: 1368060]

Obstetrics and Gynecology2023-05-01

Elagolix Improves Low Hemoglobin in Women With Uterine Fibroid-Associated Heavy Menstrual Bleeding: Post Hoc Analysis of Elaris UF-1 and UF-2 [ID: 1368055]

Obstetrics and Gynecology2023-05-01

Elagolix With Add-Back Rapidly Improves Nonbleeding Symptoms in Individuals With Fibroid-Associated Heavy Menstrual Bleeding [ID: 1368052]

Obstetrics and Gynecology2023-05-01

Elagolix Plus Add-Back Consistently Improves Uterine Fibroids-Associated Bleeding and Nonbleeding Symptoms Across Subpopulations [ID: 1368059]

Obstetrics and Gynecology2023-05-01

Population Pharmacokinetics of Elagolix in Combination with Low-Dose Estradiol/Norethindrone Acetate in Women with Uterine Fibroids.

2021-12-083 citations

Reduction of Heavy Menstrual Bleeding in Women Not Designated as Responders to Elagolix Plus Add Back Therapy for Uterine Fibroids

Journal of Women s Health2021-09-285 citations

Efficacy and safety of elagolix with add-back therapy in women with uterine fibroids and coexisting adenomyosis.

2021-05-2615 citations

Elagolix for Heavy Menstrual Bleeding in Women with Uterine Fibroids

New England Journal of Medicine2020-01-22189 citations