Obstetrics and Gynecology Commons^™

Elagolix Treatment For Up To 12 Months In Women With Heavy Menstrual Bleeding And Uterine Leiomyomas, James A Simon, Ayman Al-Hendy, David F Archer, Kurt T Barnhart, Linda D Bradley, Bruce R Carr, Thomas Dayspring, Eve C Feinberg, Veronica Gillispie, Sandra Hurtado, Jinhee Kim, Ran Liu, Charlotte D Owens, Ozgul Muneyyirci-Delale, Alice Wang, Nelson B Watts, William Schlaff

Department of Obstetrics and Gynecology Faculty Papers

Objective: To investigate the safety and efficacy of elagolix, an oral gonadotropin-releasing hormone antagonist, with hormonal add-back therapy for up to 12 months in women with heavy menstrual bleeding associated with uterine leiomyomas.

Methods: Elaris UF-EXTEND was a phase 3 extension study that evaluated an additional 6 months (up to 12 months total) of elagolix 300 mg twice daily with hormonal add-back therapy (estradiol 1 mg and norethindrone acetate 0.5 mg once daily) in women who completed an initial 6 months of the same treatment in one of two preceding phase 3 studies. The primary endpoint was the percentage of …

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

Department of Obstetrics and Gynecology Faculty Papers

BACKGROUND: Uterine fibroids are hormone-responsive neoplasms that are associated with heavy menstrual bleeding. Elagolix, an oral gonadotropin-releasing hormone antagonist resulting in rapid, reversible suppression of ovarian sex hormones, may reduce fibroid-associated bleeding.

METHODS: We conducted two identical, double-blind, randomized, placebo-controlled, 6-month phase 3 trials (Elaris Uterine Fibroids 1 and 2 [UF-1 and UF-2]) to evaluate the efficacy and safety of elagolix at a dose of 300 mg twice daily with hormonal "add-back" therapy (to replace reduced levels of endogenous hormones; in this case, estradiol, 1 mg, and norethindrone acetate, 0.5 mg, once daily) in women with fibroid-associated bleeding. An elagolix-alone …

Treatments For Opioid Use Disorder Among Pregnant And Reproductive-Aged Women., Dennis J. Hand, Vanessa L. Short, Diane J. Abatemarco

Department of Obstetrics and Gynecology Faculty Papers

The increased prevalence of opioid use disorder and access to medical insurance is subsequently increasing the likelihood that medical professionals will encounter individuals with opioid use disorder. Sharp increases in opioid use disorder among women mean that obstetricians, gynecologists, and other reproductive medicine providers may be especially likely to encounter such patients. Medical professionals' understanding of treatment for opioid use disorder and their roles in their patients' treatment may increase referrals to treatment, reduce stigma, and improve the quality of medical care. Treatment for opioid use disorder falls into four overlapping domains: medication management, medical care, behavioral/mental health care, and …