PMID- 25249568
OWN - NLM
STAT- MEDLINE
DCOM- 20150624
LR  - 20220409
IS  - 1933-7205 (Electronic)
IS  - 1933-7191 (Print)
IS  - 1933-7191 (Linking)
VI  - 21
IP  - 11
DP  - 2014 Nov
TI  - Elagolix, an oral GnRH antagonist, versus subcutaneous depot medroxyprogesterone 
      acetate for the treatment of endometriosis: effects on bone mineral density.
PG  - 1341-51
LID - 10.1177/1933719114549848 [doi]
AB  - This randomized double-blind study, with 24-week treatment and 24-week 
      posttreatment periods, evaluated the effects of elagolix (150 mg every day, 75 mg 
      twice a day) versus subcutaneous depot medroxyprogesterone acetate (DMPA-SC) on 
      bone mineral density (BMD), in women with endometriosis-associated pain (n = 
      252). All treatments induced minimal mean changes from baseline in BMD at week 24 
      (elagolix 150 mg: -0.11%/-0.47%, elagolix 75 mg: -1.29%/-1.2%, and DMPA-SC: 
      0.99%/-1.29% in the spine and total hip, respectively), with similar or less 
      changes at week 48 (posttreatment). Elagolix was associated with improvements in 
      endometriosis-associated pain, assessed with composite pelvic signs and symptoms 
      score (CPSSS) and visual analogue scale, including statistical noninferiority to 
      DMPA-SC in dysmenorrhea and nonmenstrual pelvic pain components of the CPSSS. The 
      most common adverse events (AEs) in elagolix groups were headache, nausea, and 
      nasopharyngitis, whereas the most common AEs in the DMPA-SC group were headache, 
      nausea, upper respiratory tract infection, and mood swings. This study showed 
      that similar to DMPA-SC, elagolix treatment had minimal impact on BMD over a 
      24-week period and demonstrated similar efficacy on endometriosis-associated 
      pain.
CI  - (c) The Author(s) 2014.
FAU - Carr, Bruce
AU  - Carr B
AD  - Department of Obstetrics and Gynecology, Reproductive Endocrinology & Infertility 
      Fellowship Program, University of Texas Southwestern Medical Center, Dallas, TX, 
      USA bruce.carr@utsouthwestern.edu.
FAU - Dmowski, W Paul
AU  - Dmowski WP
AD  - Institute for the Study and Treatment of Endometriosis, Oak Brook, IL, USA.
FAU - O'Brien, Chris
AU  - O'Brien C
AD  - Neurocrine Biosciences, Inc, San Diego, CA USA.
FAU - Jiang, Ping
AU  - Jiang P
AD  - AbbVie Inc, North Chicago, IL, USA.
FAU - Burke, Joshua
AU  - Burke J
AD  - Neurocrine Biosciences, Inc, San Diego, CA USA.
FAU - Jimenez, Roland
AU  - Jimenez R
AD  - Neurocrine Biosciences, Inc, San Diego, CA USA.
FAU - Garner, Elizabeth
AU  - Garner E
AD  - AbbVie Inc, North Chicago, IL, USA.
FAU - Chwalisz, Kristof
AU  - Chwalisz K
AD  - AbbVie Inc, North Chicago, IL, USA.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20140923
PL  - United States
TA  - Reprod Sci
JT  - Reproductive sciences (Thousand Oaks, Calif.)
JID - 101291249
RN  - 0 (Delayed-Action Preparations)
RN  - 0 (Hormone Antagonists)
RN  - 0 (Hydrocarbons, Fluorinated)
RN  - 0 (Pyrimidines)
RN  - 33515-09-2 (Gonadotropin-Releasing Hormone)
RN  - 5B2546MB5Z (elagolix)
RN  - HSU1C9YRES (Medroxyprogesterone)
SB  - IM
MH  - Absorptiometry, Photon
MH  - Administration, Oral
MH  - Adult
MH  - Bone Density/*drug effects
MH  - Delayed-Action Preparations
MH  - Endometriosis/complications/diagnosis/*drug therapy/metabolism
MH  - Female
MH  - Gonadotropin-Releasing Hormone/*antagonists & inhibitors/metabolism
MH  - Hormone Antagonists/*administration & dosage/adverse effects
MH  - Humans
MH  - Hydrocarbons, Fluorinated/*administration & dosage/adverse effects
MH  - Injections, Subcutaneous
MH  - Medroxyprogesterone/*administration & dosage/adverse effects
MH  - Pain Measurement
MH  - Pelvic Pain/diagnosis/drug therapy/etiology
MH  - Pyrimidines/*administration & dosage/adverse effects
MH  - Texas
MH  - Time Factors
MH  - Treatment Outcome
MH  - United States
PMC - PMC4212335
OTO - NOTNLM
OT  - GnRH antagonists
OT  - elagolix
OT  - endometriosis
OT  - pelvic pain
COIS- Declaration of Conflicting Interests: The author(s) declared the following 
      potential conflicts of interest with respect to the research, authorship, and/or 
      publication of this article: BC has been a consultant for AbbVie Inc. WPD has 
      been a consultant for Neurocrine Biosciences, Inc and AbbVie Inc. JB, RJ, and CO 
      are Neurocrine Biosciences, Inc employees and own Neurocrine Biosciences, Inc 
      stock. KC and PJ are AbbVie Inc employees and own AbbVie Inc stock; EG is a 
      former AbbVie Inc employee.
EDAT- 2014/09/25 06:00
MHDA- 2015/06/25 06:00
PMCR- 2015/11/01
CRDT- 2014/09/25 06:00
PHST- 2014/09/25 06:00 [entrez]
PHST- 2014/09/25 06:00 [pubmed]
PHST- 2015/06/25 06:00 [medline]
PHST- 2015/11/01 00:00 [pmc-release]
AID - 1933719114549848 [pii]
AID - 10.1177_1933719114549848 [pii]
AID - 10.1177/1933719114549848 [doi]
PST - ppublish
SO  - Reprod Sci. 2014 Nov;21(11):1341-51. doi: 10.1177/1933719114549848. Epub 2014 Sep 
      23.