Treatment of Endometriosis-Associated Pain with Elagolix, an Oral GnRH Antagonist
Open accessAbstract
BACKGROUND: Endometriosis is a chronic, estrogen-dependent condition that causes dysmenorrhea and pelvic pain. Elagolix, an oral, nonpeptide, gonadotropin-releasing hormone (GnRH) antagonist, produced partial to nearly full estrogen suppression in previous studies. METHODS: We performed two similar, double-blind, randomized, 6-month phase 3 trials (Elaris Endometriosis I and II [EM-I and EM-II]) to evaluate the effects of two doses of elagolix - 150 mg once daily (lower-dose group) and 200 mg twice daily (higher-dose group) - as compared with placebo in women with surgically diagnosed endometriosis and moderate or severe endometriosis-associated pain. The two primary efficacy end points were the proportion of women who had a clinical response with respect to dysmenorrhea and the proportion who had a clinical response with respect to nonmenstrual pelvic pain at 3 months. Each of these end points was measured as a clinically meaningful reduction in the pain score and a decreased or stable use of rescue analgesic agents, as recorded in a daily electronic diary. RESULTS: A total of 872 women underwent randomization in Elaris EM-I and 817 in Elaris EM-II; of these women, 653 (74.9%) and 632 (77.4%), respectively, completed the intervention. At 3 months, a significantly greater proportion of women who received each elagolix dose met the clinical response criteria for the two primary end points than did those who received placebo. In Elaris EM-I, the percentage of women who had a clinical response with respect to dysmenorrhea was 46.4% in the lower-dose elagolix group and 75.8% in the higher-dose elagolix group, as compared with 19.6% in the placebo group; in Elaris EM-II, the corresponding percentages were 43.4% and 72.4%, as compared with 22.7% (P<0.001 for all comparisons). In Elaris EM-I, the percentage of women who had a clinical response with respect to nonmenstrual pelvic pain was 50.4% in the lower-dose elagolix group and 54.5% in the higher-dose elagolix group, as compared with 36.5% in the placebo group (P<0.001 for all comparisons); in Elaris EM-II, the corresponding percentages were 49.8% and 57.8%, as compared with 36.5% (P=0.003 and P<0.001, respectively). The responses with respect to dysmenorrhea and nonmenstrual pelvic pain were sustained at 6 months. Women who received elagolix had higher rates of hot flushes (mostly mild or moderate), higher levels of serum lipids, and greater decreases from baseline in bone mineral density than did those who received placebo; there were no adverse endometrial findings. CONCLUSIONS: Both higher and lower doses of elagolix were effective in improving dysmenorrhea and nonmenstrual pelvic pain during a 6-month period in women with endometriosis-associated pain. The two doses of elagolix were associated with hypoestrogenic adverse effects. (Funded by AbbVie; Elaris EM-I and EM-II ClinicalTrials.gov numbers, NCT01620528 and NCT01931670 .).
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In two phase 3 trials, during 6 months treatment, elagolix dramatically reduced dysmenorrhea and non-menstrual pelvic discomfort.
“In both trials, during the 6 months treatment, elagolix dramatically reduced dysmenorrhea and non-menstrual pelvic discomfort.”
From Hormonal treatments for endometriosis: The endocrine background (2022) · cites this paper as [173]
In a study of about 1700 women with moderate or severe endometriosis pain, elagolix at 150 mg once daily or 200 mg twice daily significantly reduced pelvic pain and sex-related pain.
“The results of a study in which about 1700 women with moderate or severe pain in endometriosis participated played a part in the above decision. Doses of this drug—150 mg once a day or 200 mg twice a day—significantly reduced the most common types of endometrial pain: pelvic pain and sex-related pain.”
From Endometriosis: Epidemiology, Classification, Pathogenesis, Treatment and Genetics (Review of Literature) (2021) · cites this paper as [117]
Elagolix is approved by the FDA for treatment of moderate to severe pain associated with endometriosis.
“The latest drug to be approved by the Food and Drug Administration (FDA) is elagolix, a drug for the treatment of moderate to severe pain associated with endometriosis [117].”
From Endometriosis: Epidemiology, Classification, Pathogenesis, Treatment and Genetics (Review of Literature) (2021) · cites this paper as [117]
An oral GnRH antagonist (elagolix) was reported to be effective for reducing endometriosis-related symptoms.
“Recently, an oral GnRH antagonist (elagolix) was reported to be effective for reducing endometriosis‐related symptoms.”
From Extra-pelvic endometriosis: a review. (2020) · cites this paper as [97]
In Elaris EM-II, the percentages of women with improvement in non-menstrual pelvic pain were 49.8% with elagolix 150 mg once daily and 57.8% with elagolix 200 mg twice daily, compared with 36.5% in the placebo group.
“In Elaris EM-II, corresponding percentages were 49.8% and 57.8% (compared with 36.5% in the placebo group).”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [102]
In the EM-I and EM-II trials, mean decreases in BMD in the lumbar spine, femoral neck and total hip after six months of treatment were significantly greater in patients receiving elagolix than in those given placebo, excluding femoral neck BMD at a dose of 150 mg in Elaris EM-I.
“In the EM-I and -II trials, Taylor et al. [102] reported that mean decreases in BMD in the lumbar spine, femoral neck and total hip after six months of treatment were significantly greater in patients receiving elagolix than in those given a placebo (excluding femoral neck BMD at a dose of 150 mg in Elaris EM-I (Figure 3).”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [102]
In Elaris EM-II, the percentages of women with clinical improvement in dysmenorrhea were 43.4% with elagolix 150 mg once daily and 72.4% with elagolix 200 mg twice daily, compared with 22.7% in the placebo group.
“In Elaris EM-II, corresponding percentages were 43.4% and 72.4% (compared with 22.7% in the placebo group).”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [102]
Percentages of women experiencing hot flushes at elagolix 200 mg twice daily were 42.3%, 47.6%, 72% and 77% in Elaris-I, -II, -III and -IV.
“At 200 mg (twice daily), percentages were respectively 42.3%, 47.6%, 72% and 77% [102,103].”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [102]
Alleviation of both dysmenorrhea and non-menstrual pelvic pain with elagolix was sustained for six months.
“Overall, alleviation of both dysmenorrhea and non-menstrual pelvic pain were sustained for six months (Table 1).”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [102]
In both Elaris EM-I and EM-II, only women treated with elagolix 200 mg twice daily showed a statistically significant greater reduction in dyspareunia after three months of treatment compared with placebo.
“In both studies, only women treated with elagolix at a dose of 200 mg twice daily showed a statistically significant greater reduction in dyspareunia after three months of treatment (compared with the placebo).”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [102]
Use of elagolix 200 mg twice daily causes strong suppression of E2 and marked improvements in dysmenorrhea, non-menstrual pelvic pain and dyspareunia, albeit at the cost of more hot flushes and a more pronounced decrease in BMD.
“In conclusion, use of elagolix 200 mg twice daily causes strong suppression of E2 and marked improvements in dysmenorrhea, non-menstrual pelvic pain and dyspareunia, albeit at the cost of more hot flushes and a more pronounced decrease in BMD (Figure 4).”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [102]
The percentage of patients with a decrease of >5% from baseline in lumbar spine BMD was higher in the elagolix 200 mg twice daily group in all studies.
“The percentage of patients with a decrease of >5% from baseline in lumbar spine BMD was higher in the elagolix 200 mg twice daily group in all studies.”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [102]
The pharmacokinetic properties of elagolix at 150 mg once daily and 200 mg twice daily do not appear to be affected, to a clinically meaningful extent, by body weight, body mass index, race/ethnicity or the presence of endometriosis.
“Overall, the pharmacokinetic properties of elagolix at 150 mg once daily and 200 mg twice daily do not appear to be affected, to a clinically meaningful extent, by body weight, body mass index, race/ethnicity or the presence of endometriosis [102,103,107].”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [102]
Elagolix causes a dose-dependent decrease in BMD.
“Elagolix causes a dose-dependent decrease in BMD.”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [102]
The most frequently reported side effects of elagolix were hot flushes, depending on the dose.
“Regarding side effects, the most frequently reported were hot flushes, depending on the dose.”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [102]
Percentages of women experiencing hot flushes at elagolix 150 mg once daily were 23.7%, 22.6%, 44% and 36% in Elaris-I, -II, -III and -IV.
“Percentages of women experiencing hot flushes at a dose of 150 mg (once daily) were respectively 23.7%, 22.6%, 44% and 36% in Elaris-I, -II, -III and -IV.”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [102]
In Elaris EM-I, the percentage of women with improvement in non-menstrual pelvic pain was 50.4% with elagolix 150 mg once daily and 54.5% with elagolix 200 mg twice daily, compared with 36.5% in the placebo group.
“In Elaris EM-I, the percentage of women who noted an improvement in non-menstrual pelvic pain was 50.4% with elagolix 150 mg once daily and 54.5% with elagolix 200 mg twice daily (compared with 36.5% in the placebo group).”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [102]
In Elaris EM-I, the percentage of women with clinical improvement in dysmenorrhea was 46.4% with elagolix 150 mg once daily and 75.8% with elagolix 200 mg twice daily, compared with 19.6% in the placebo group.
“The percentage of women who experienced a clinical improvement in dysmenorrhea was 46.4% with elagolix 150 mg once daily and 75.8% with elagolix 200 mg twice daily (compared with 19.6% in the placebo group).”
From Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review (2021) · cites this paper as [102]
Even if majority of patients were satisfied with elagolix therapy, as many as 40% indicated unsatisfactory improvement of pain symptoms.
“Even if the majority of patients were satisfied with this therapy, as many as 40% of patients indicated unsatisfactory improvement of pain symptoms ( 69 ).”
From Is intracrinology of endometriosis relevant in clinical practice? A systematic review on estrogen metabolism (2022) · cites this paper as [69]
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- Authors
- Taylor, H. S., Giudice, L. C., Lessey, B. A., Abrao, M. S., Kotarski, J., Archer, D. F., Diamond, M. P., Surrey, E., Johnson, N. P., Watts, N. B., Gallagher, J. C., Simon, J. A., Carr, B. R., Dmowski, W. P., Leyland, N., Rowan, J. P., Duan, W. R., Ng, J., Schwefel, B., Thomas, J. W., Jain, R. I., & Chwalisz, K.
- Affiliations
- Creighton University (US)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2017-07-06
- Volume
- 377
- Issue
- 1
- Pages
- 28-40
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2616333165
- Cited by
- 511
- References
- 36
- Citations by year
- 2026: 53 · 2025: 56 · 2024: 62 · 2023: 53 · 2022: 42 · 2021: 67 · 2020: 74 · 2019: 45 · 2018: 40 · 2017: 18
- FWCI
- 56.56
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- LA Referencia (Red Federada de Repositorios Institucionales de Publicaciones Científicas) (publishedVersion, other-oa)
- PubMed (publishedVersion)
- eScholarship (California Digital Library) (submittedVersion)
- Creighton Digital Repository (CDR) (submittedVersion)
- 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 › Public Health, Environmental and Occupational Health › Ectopic Pregnancy Diagnosis and Management
- Keywords
- endometriosis, elagolix, GnRH antagonist, dysmenorrhea, estrogen suppression, rescue analgesic consumption, pain management, dose comparison, chronic pelvic pain
- MeSH terms
- Adolescent, Adult, Dose-Response Relationship, Drug, Double-Blind Method, Dysmenorrhea, Endometriosis, Estrogen Antagonists, Female, Humans, Hydrocarbons, Fluorinated, Gonadotropin-Releasing Hormone, Lipids, Middle Aged, Pyrimidines, Bone Density, Premenopause, 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 ›
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