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Elagolix for the management of heavy menstrual bleeding associated with uterine fibroids: results from a phase 2a proof-of-concept study.
- Source :
-
Fertility and sterility [Fertil Steril] 2017 Jul; Vol. 108 (1), pp. 152-160.e4. Date of Electronic Publication: 2017 Jun 01. - Publication Year :
- 2017
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Abstract
- Objective: To evaluate the safety and efficacy of elagolix vs. placebo and elagolix with low-dose E <subscript>2</subscript> /progestogen add-back therapy.<br />Design: Proof-of-concept, dose-ranging, multiple-cohort study.<br />Setting: Clinics.<br />Patient(s): Premenopausal women with fibroids and heavy menstrual bleeding (menstrual blood loss [MBL] >80 mL per cycle).<br />Intervention(s): Three months' treatment with elagolix alone: 100 mg twice daily (BID), 200 mg BID, 300 mg BID, 400 mg once daily (QD), or 600 mg QD (all but the 600 mg QD arm were placebo controlled); or elagolix plus add-back therapy: 200 mg BID plus continuous low-dose E <subscript>2</subscript> 0.5 mg/norethindrone acetate 0.1 mg or elagolix 300 mg BID plus E <subscript>2</subscript> 1 mg continuously and cyclical P 200 mg.<br />Main Outcome Measure(s): Least-squares mean percentage change in MBL; adverse events (AEs).<br />Result(s): Mean age was 41.8 years; 73.8% were black; mean baseline MBL was 267 mL. Of randomized women (elagolix alone, n = 160; placebo, n = 50; elagolix with add-back therapy, n = 61), 228 of 271 completed the 3-month treatment period. The MBL percentage change from baseline to last 28 days was significantly greater with elagolix alone (range, -72% to -98%; dose-dependent reduction was highest with 300 mg BID) vs. placebo (range, -8% to -41%); mean percentage changes with add-back regimens were -80% to -85%. Overall AEs were dose independent (elagolix alone, 70.0%-81.3%) but lower with placebo (56.0%) and add-back regimens (55.6%-70.6%). Hot flush was the most common AE (elagolix alone, 45.5%-62.5%; placebo, 12.0%; add-back regimens, 18.5%-26.5%).<br />Conclusion(s): Elagolix significantly reduced heavy menstrual bleeding in women with fibroids. Low-dose add-back regimens substantially reduced flushing.<br />Clinical Trial Registration Number: NCT01441635.<br /> (Copyright © 2017 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.)
- Subjects :
- Adult
Combined Modality Therapy methods
Dose-Response Relationship, Drug
Female
Gonadotropin-Releasing Hormone antagonists & inhibitors
Humans
Hydrocarbons, Fluorinated adverse effects
Leiomyoma diagnosis
Leiomyoma drug therapy
Menorrhagia diagnosis
Pilot Projects
Pyrimidines adverse effects
Treatment Outcome
Uterine Neoplasms diagnosis
Uterine Neoplasms drug therapy
Hormone Replacement Therapy methods
Hydrocarbons, Fluorinated administration & dosage
Leiomyoma complications
Menorrhagia drug therapy
Menorrhagia etiology
Pyrimidines administration & dosage
Uterine Neoplasms complications
Subjects
Details
- Language :
- English
- ISSN :
- 1556-5653
- Volume :
- 108
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Fertility and sterility
- Publication Type :
- Academic Journal
- Accession number :
- 28579415
- Full Text :
- https://doi.org/10.1016/j.fertnstert.2017.05.006