Elagolix Suppresses Ovulation in a Dose-Dependent Manner: Results From a 3-Month, Randomized Study in Ovulatory Women

David F. Archer, Archer DF, Juki Ng, Kristof Chwalisz, Chwalisz K, Kristof Chwalisż, Chiu YL, Yi-Lin Chiu, Yi‐Lin Chiu, Eve C. Feinberg, Feinberg EC, Charles E. Miller, Miller CE, Feldman RA, Robert A Feldman, Robert Feldman, Klein CE, Cheri E. Klein
The Journal of clinical endocrinology and metabolism · 2019 · vol. 105(3) , pp. 821–832 · doi:10.1210/clinem/dgz086 · PMID:31650182 · W2981884531
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Elagolix suppressed ovulation and key sex hormones in a dose-dependent manner, with the lowest ovulation rates observed at the highest elagolix dose combined with hormone add-back therapy.

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Abstract

CONTEXT: Elagolix is an oral gonadotropin-releasing hormone (GnRH) antagonist recently approved for the treatment of endometriosis-associated pain and being developed for heavy menstrual bleeding associated with uterine fibroids. OBJECTIVE: The objective was to evaluate the effects of elagolix on ovulation and ovarian sex hormones. DESIGN AND SETTING: This was a randomized, open-label, multicenter study. PARTICIPANTS: Participants were healthy ovulatory women aged 18 to 40 years. INTERVENTIONS: Elagolix was administered orally for 3 continuous 28-day dosing intervals at 100 to 200 mg once daily (QD), 100 to 300 mg twice daily (BID), and 300 mg BID plus estradiol/norethindrone acetate (E2/NETA) 1/0.5 mg QD. MAIN OUTCOME MEASURES: The main outcomes measures were ovulation rates measured by transvaginal ultrasound, progesterone concentrations, and hormone suppression. RESULTS: Elagolix suppressed ovulation in a dose-dependent manner. The percentage of women who ovulated was highest at 100 mg QD (78%), intermediate at 150 and 200 mg QD and 100 mg BID (47%-57%), and lowest at 200 and 300 mg BID (32% and 27%, respectively). Addition of E2/NETA to elagolix 300 mg BID further suppressed the ovulation rate to 10%. Elagolix also suppressed luteinizing hormone and follicle stimulating hormone in a dose-dependent manner, leading to dose-dependent suppression of estradiol and progesterone. Elagolix had no effect on serum biomarker of ovarian reserve, and reduced endometrial thickness compared to the screening cycle. CONCLUSION: Women being treated with elagolix may ovulate and should use effective methods of contraception. The rate of ovulation was lowest with elagolix 300 mg BID plus E2/NETA 1/0.5 mg QD.

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Condition tags

endometriosis

MeSH descriptors

Endometrium Gonadotropin-Releasing Hormone Hydrocarbons, Fluorinated Menorrhagia Ovulation Pyrimidines Adolescent Adolescent Adult Adult Dose-Response Relationship, Drug Dose-Response Relationship, Drug Endometrium Endometrium Female Female Follow-Up Studies Follow-Up Studies Gonadotropin-Releasing Hormone Gonadotropin-Releasing Hormone

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