CoChat
Sign Up
Cited by 139Endometriosis Research and TreatmentMenstrual Health and DisordersEctopic Pregnancy Diagnosis and Management

The DOI matches its Crossref record; 19 of the 19 references it cites were found in a registry or an index.

Long-Term Outcomes of Elagolix in Women With Endometriosis: Results From Two Extension Studies

Open access
Surrey, Eric, Taylor, Hugh S., Giudice, Linda, Lessey, Bruce A., Abrao, Mauricio S., Archer, David F., Diamond, Michael P., Johnson, Neil P., Watts, Nelson B., Gallagher, J. Chris, Simon, James A., Carr, Bruce R., Dmowski, W. Paul, Leyland, Nicholas, Singh, Sukhbir S., Rechberger, Tomasz, Agarwal, Sanjay K., Duan, W. Rachel, Schwefel, Brittany, Thomas, James W., Peloso, Paul M., Ng, Juki, Soliman, Ahmed M., Chwalisz, Kristof·2018·Obstetrics & Gynecology
DOI 10.1097/aog.0000000000002675
Open this paper in CoChat — free accountOpen PDF

Abstract

OBJECTIVE: To evaluate the efficacy and safety of elagolix, an oral, nonpeptide gonadotropin-releasing hormone antagonist, over 12 months in women with endometriosis-associated pain. METHODS: Elaris Endometriosis (EM)-III and -IV were extension studies that evaluated an additional 6 months of treatment after two 6-month, double-blind, placebo-controlled phase 3 trials (12 continuous treatment months) with two elagolix doses (150 mg once daily and 200 mg twice daily). Coprimary efficacy endpoints were the proportion of responders (clinically meaningful pain reduction and stable or decreased rescue analgesic use) based on average monthly dysmenorrhea and nonmenstrual pelvic pain scores. Safety assessments included adverse events, clinical laboratory tests, and endometrial and bone mineral density assessments. The power of Elaris EM-III and -IV was based on the comparison to placebo in Elaris EM-I and -II with an expected 25% dropout rate. RESULTS: Between December 28, 2012, and October 31, 2014 (Elaris EM-III), and between May 27, 2014, and January 6, 2016 (Elaris EM-IV), 569 participants were enrolled. After 12 months of treatment, Elaris EM-III responder rates for dysmenorrhea were 52.1% at 150 mg once daily (Elaris EM-IV=50.8%) and 78.1% at 200 mg twice daily (Elaris EM-IV=75.9%). Elaris EM-III nonmenstrual pelvic pain responder rates were 67.8% at 150 mg once daily (Elaris EM-IV=66.4%) and 69.1% at 200 mg twice daily (Elaris EM-IV=67.2%). After 12 months of treatment, Elaris EM-III dyspareunia responder rates were 45.2% at 150 mg once daily (Elaris EM-IV=45.9%) and 60.0% at 200 mg twice daily (Elaris EM-IV=58.1%). Hot flush was the most common adverse event. Decreases from baseline in bone mineral density and increases from baseline in lipids were observed after 12 months of treatment. There were no adverse endometrial findings. CONCLUSION: Long-term elagolix treatment provided sustained reductions in dysmenorrhea, nonmenstrual pelvic pain, and dyspareunia. The safety was consistent with reduced estrogen levels and no new safety concerns were associated with long-term elagolix use. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT01760954 and NCT02143713.

Overview

Integrity signals

Registry

Crossref · 10.1097/aog.0000000000002675

Cites

19 of 19 references verified0 citation errors · 0 not checkable

Statistics

Recomputing p-values needs the paper’s full text.

Verification

Claims the paper makes

The text we found for this paper looks like another document, so its claims and self-check weren’t run. The registry and citation checks still apply.

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

The text we found for this paper looks like another document, so the self-check wasn’t run.

Citations

Cites

Flagged first, then by citations

Show all 19 references

Cited by

Sorted by citations

See all 139

Related

See all

Metadata

Authors
Surrey, E., Taylor, H. S., Giudice, L., Lessey, B. A., Abrao, M. S., Archer, D. F., Diamond, M. P., Johnson, N. P., Watts, N. B., Gallagher, J. C., Simon, J. A., Carr, B. R., Dmowski, W. P., Leyland, N., Singh, S. S., Rechberger, T., Agarwal, S. K., Duan, W. R., Schwefel, B., Thomas, J. W., Peloso, P. M., Ng, J., Soliman, A. M., & Chwalisz, K.
Affiliations
Creighton University (US)
ORCID
Venue
Obstetrics & Gynecology
Publisher
Ovid Technologies (Wolters Kluwer Health)
Published
2018-07
Volume
132
Issue
1
Pages
147-160
ISSN
0029-7844 (ISSN-L)
DOI
10.1097/aog.0000000000002675
OpenAlex
W2915078548
Cited by
139
References
19
Citations by year
2026: 19 · 2025: 13 · 2024: 15 · 2023: 14 · 2022: 15 · 2021: 22 · 2020: 20 · 2019: 14 · 2018: 6
FWCI
16.53
Type
journal article
Language
en
Open access
Locations
  • Obstetrics and Gynecology (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Reproductive Medicine › Endometriosis Research and Treatment
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Menstrual Health and Disorders
  • Health Sciences › Medicine › Obstetrics and Gynecology › Ectopic Pregnancy Diagnosis and Management
Keywords
elagolix, endometriosis, endometriosis-associated pain, dysmenorrhea, dyspareunia, GnRH antagonist, long-term efficacy, long-term safety, bone mineral density, hot flashes, lipid changes, rescue analgesic consumption, dose comparison, women's health
MeSH terms
Adolescent, Adult, Double-Blind Method, Drug Administration Schedule, Dysmenorrhea, Dyspareunia, Endometriosis, Female, Humans, Hydrocarbons, Fluorinated, Gonadotropin-Releasing Hormone, Middle Aged, Pyrimidines, Time Factors, Treatment Outcome, Pelvic Pain, Hot Flashes, Young Adult

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review