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Elagolix for Heavy Menstrual Bleeding in Women with Uterine Fibroids

by Kim, JinHee , Archer, David F , Bradley, Linda D , Soliman, Ahmed M , Owens, Charlotte D , Muneyyirci-Delale, Ozgul , Rodriguez-Ginorio, Henry , Ackerman, Ronald T , Carr, Bruce R , Simon, James A , Schlaff, William D , Poindexter, Alfred , Al-Hendy, Ayman , Liu, Ran , Watts, Nelson B , Feinberg, Eve C , Mabey, R. Garn , Puscheck, Elizabeth E , Hurtado, Sandra M , Barnhart, Kurt T , Stewart, Elizabeth A

in 17β-Estradiol / Acetic acid / Adult / Bleeding / Bone density / Bone Density - drug effects / Bone mineral density / Double-Blind Method / Drug Therapy, Combination / Estradiol - therapeutic use / Estrogens - therapeutic use / Female / Fibroids / Gonadotropin-releasing hormone / Gonadotropin-Releasing Hormone - antagonists & inhibitors / Gonadotropins / Hemoglobin / Hormones / Hot Flashes - chemically induced / Humans / Hydrocarbons, Fluorinated - adverse effects / Hydrocarbons, Fluorinated - therapeutic use / Hysterectomy / Leiomyoma - complications / Menorrhagia - drug therapy / Menorrhagia - etiology / Menstruation / Middle Aged / Pituitary (anterior) / Pyrimidines - adverse effects / Pyrimidines - therapeutic use / Quality of Life / Questionnaires / Severity of Illness Index / Sex hormones / Surgery / Surveys and Questionnaires / Ultrasonic imaging / Uterus / Womens health

2020

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Elagolix for Heavy Menstrual Bleeding in Women with Uterine Fibroids

2020

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Elagolix for Heavy Menstrual Bleeding in Women with Uterine Fibroids

2020

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Journal Article

Elagolix for Heavy Menstrual Bleeding in Women with Uterine Fibroids

Kim, JinHee,

Archer, David F,

Bradley, Linda D,

Soliman, Ahmed M,

Owens, Charlotte D,

Muneyyirci-Delale, Ozgul,

Rodriguez-Ginorio, Henry,

Ackerman, Ronald T,

Carr, Bruce R,

Simon, James A,

Schlaff, William D,

Poindexter, Alfred,

Al-Hendy, Ayman,

Liu, Ran,

Watts, Nelson B,

Feinberg, Eve C,

Mabey, R. Garn,

Puscheck, Elizabeth E,

Hurtado, Sandra M,

Barnhart, Kurt T,

Stewart, Elizabeth A

2020

Overview

In two identical, double-blind, randomized, 6-month phase 3 trials, elagolix (an oral gonadotropin-releasing hormone antagonist), administered with hormonal add-back therapy (estradiol, 1 mg, and norethindrone acetate, 0.5 mg, once daily) was more effective in reducing heavy menstrual bleeding in women with uterine fibroids than placebo. Bone loss was attenuated with add-back therapy, as compared with elagolix alone.

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Publisher

Massachusetts Medical Society

Subject

/ Adult

/ Bone Density - drug effects

/ Bone mineral density