Michael C. Snabes

OBJECTIVE: To evaluate the safety and efficacy of elagolix 150 mg once-daily monotherapy in patients with heavy menstrual bleeding associated with uterine leiomyomas. METHODS: A phase 4, randomized, double-blind, placebo-controlled, 6-mont…

BACKGROUND: Elagolix (ELA) 200 mg twice daily is an oral treatment approved for moderate-to-severe endometriosis-associated pain. However, the clinical use of ELA is limited by potential hypoestrogenic effects, including the loss of bone mi…

BACKGROUND: Elagolix, an approved oral treatment for endometriosis-associated pain, has been associated with hypoestrogenic effects when used as monotherapy. Hormonal add-back therapy has the potential to mitigate these effects. OBJECTIVE:…

INTRODUCTION: Herein, we report updated safety results to 36 months from an ongoing phase 3, 48-month study evaluating the long-term safety of elagolix (ELA) with add-back (AB) for endometriosis-associated pain (EAP) (NCT03213457). METHODS:…

OBJECTIVE: Evaluate the efficacy and safety of elagolix, a GnRH antagonist, to treat polycystic ovarian syndrome (PCOS). DESIGN: A phase 2, multicenter, double-blind, randomized, placebo-controlled trial. SETTING: Outpatient and academic …

INTRODUCTION: Elagolix is an oral GnRH antagonist approved for the treatment of moderate to severe endometriosis-associated pain (EAP) in the US, Canada, and Israel. Hormonal add-back therapy (1 mg estradiol/0.5 mg norethindrone acetate QD)…

BACKGROUND: Women with endometriosis are prescribed opioids for pain relief but may be vulnerable to chronic opioid use given their comorbidity profile. METHODS: A cohort study was conducted in the Clinformatics™ DataMart database between …

BACKGROUND: Elagolix is an oral, gonadotropin-releasing hormone (GnRH) receptor antagonist, that significantly reduces dysmenorrhea and non-menstrual pelvic pain (NMPP) in women with moderate to severe endometriosis-associated pain. METHOD…

BACKGROUND: Dyspareunia experienced by women diagnosed with endometriosis is associated with a decreased health-related quality of life (HRQoL). AIM: We evaluated the relationship of clinically meaningful improvements in dyspareunia with H…

Elagolix, a gonadotrophin-releasing hormone antagonist, is used in premenopausal women with endometriosis. There is a risk of bone loss with elagolix, but the long-term effects of BMD loss later in life cannot be directly assessed and has n…

BACKGROUND: Endometriosis is a common problem in women of reproductive age and has impacts on health-related quality of life and productivity. Fatigue is an important part of the burden of endometriosis, it is not often included as an endpo…

OBJECTIVE: To evaluate the utility, responsiveness, and thresholds for clinically meaningful change of a numerical rating scale for worst pain associated with dysmenorrhea (NRS-DYS) and nonmenstrual pelvic pain (NRS-NMPP) in women with mode…

BACKGROUND: Endometriosis-related pain symptoms have a negative impact on health-related quality of life and productivity. In fact, as endometriosis-related symptom severity and the number of symptoms experienced increases, health-related q…

Background: The daily pain burden experienced by women with endometriosis has not been well studied. Objective: To characterize baseline pain among women with moderate-to-severe endometriosis-associated pain enrolled in phase 3 studies of e…

OBJECTIVE: To estimate the impact of elagolix on work loss due to endometriosis-associated pain. DESIGN: Post hoc analysis of data from the Elaris I and II clinical trials. SETTING: Not applicable. PATIENT(S): Employed women ages 18-49 y…

OBJECTIVE: To evaluate the efficacy of elagolix, an oral GnRH antagonist, for the reduction of fatigue in women with moderate or severe endometriosis-associated pain. DESIGN: Randomized, double-blind, multicenter, placebo-controlled phase …

INTRODUCTION: Women with endometriosis are prescribed opioids for pain relief but may have other risk factors for chronic opioid use. The identification of predictors of chronic use in this population may provide clinical guidance for treat…

Objective: Endometriosis impacts health-related quality of life. The objective was to assess the validity and responsiveness of the Health-Related Productivity Questionnaire, version 2 (HRPQ). Methods: Outcome measures (Endometriosis Health…

Objective: To evaluate the responsiveness of the Endometriosis Health Profile-30 (EHP-30) and ascertain score changes that are indicative of response to treatment. A post hoc analysis of two Phase III, double-blind, placebo-controlled, rand…

INTRODUCTION: Women with endometriosis may be prescribed opioids for management of endometriosis-related pain symptoms or in the context of surgical procedures. Once exposed, these women may be vulnerable to chronic opioid use given their c…