Elagolix Evidence: Trial Results and Peer-Reviewed Publications

Hipa.ai Research · Source: PubMed & ClinicalTrials.gov / AACT · Last updated:

The clinical evidence base for Elagolix comprises 62 peer-reviewed publications across 15 journals, 14 pivotal-trial primary-outcome rows reported to ClinicalTrials.gov, spanning indications including Endometriosis, Leiomyoma, Anovulation, and Polycystic Ovary Syndrome. Most recent publication: Impact of demographic and clinical factors on elagolix plus add-back therapy effects on patient-reported nonbleeding symptoms in women with heavy menstrual bleeding and uterine fibroids: a post hoc analysis of data from two clinical trials., F S Rep, 2026.

Top peer-reviewed publications

Curated set of pivotal-trial result papers and recent publications in high-tier journals.

  1. Treatment of Endometriosis-Associated Pain with Elagolix, an Oral GnRH Antagonist.
    Taylor HS, Giudice LC, Lessey BA, et al. · N Engl J Med · 2017
    PubMed: PMID 28525302 · NCT01931670 (ELARIS EM-II) · Endometriosis
  2. Effect of prolonged gonadotropin-releasing hormone agonist therapy on the outcome of in vitro fertilization-embryo transfer in patients with endometriosis.
    Surrey ES, Silverberg KM, Surrey MW, et al. · Fertil Steril · 2002
    PubMed: PMID 12372443 · NCT04445025 · Endometriosis
  3. Long-Term Outcomes of Elagolix in Women With Endometriosis: Results From Two Extension Studies.
    Surrey E, Taylor HS, Giudice L, et al. · Obstet Gynecol · 2019
    PubMed: PMID 29889764 · NCT04060992 · Anovulation
  4. Elagolix for Heavy Menstrual Bleeding in Women with Uterine Fibroids.
    Schlaff WD, Ackerman RT, Al-Hendy A, et al. · N Engl J Med · 2020
    PubMed: PMID 31971678 · NCT04856306 (Magical) · Leiomyoma
  5. Dose-Dependent Suppression of Gonadotropins and Ovarian Hormones by Elagolix in Healthy Premenopausal Women.
    Ng J, Chwalisz K, Carter DC, et al. · J Clin Endocrinol Metab · 2017
    PubMed: PMID 28323948 · NCT04060992 · Anovulation
  6. Gonadotropin-releasing hormone analogs: Understanding advantages and limitations.
    Kumar P, Sharma A · J Hum Reprod Sci · 2014
    PubMed: PMID 25395741 · NCT04060992 · Anovulation
  7. Elagolix (Orilissa)--an oral GnRH antagonist for endometriosis pain.
    Med Lett Drugs Ther · 2018
    PubMed: PMID 30383729 · NCT04060992 · Anovulation
  8. GnRH agonist versus GnRH antagonist in in vitro fertilization and embryo transfer (IVF/ET).
    Depalo R, Jayakrishan K, Garruti G, et al. · Reprod Biol Endocrinol · 2013
    PubMed: PMID 22500852 · NCT04060992 · Anovulation

Primary-outcome results across pivotal trials

Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.

TrialIndicationPrimary endpointArmValue
NCT01620528
ELARIS EM-I
EndometriosisPercentage of Responders at Month 3 Based on Daily Assessment of Dysmenorrhea (DYS)
At Month 3 of the Treatment Period
Elagolix 150 mg QD46.4 percentage of participants
Elagolix 200 mg BID75.8 percentage of participants
Placebo19.6 percentage of participants
NCT01620528
ELARIS EM-I
EndometriosisPercentage of Responders at Month 3 Based on Daily Assessment of Non-Menstrual Pelvic Pain (NMPP)
At Month 3 of Treatment Period
Elagolix 150 mg QD50.4 percentage of participants
Elagolix 200 mg BID54.5 percentage of participants
Placebo36.5 percentage of participants
NCT01760954EndometriosisPercentage of Participants With a Response for Dysmenorrhea at Month 6 Based on Daily Assessment
Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and Month 6
Elagolix/Elagolix 150 mg QD52.1 percentage of participants
Elagolix/Elagolix 200 mg BID78.2 percentage of participants
Placebo/Elagolix 150 mg QD32.6 percentage of participants
Placebo/Elagolix 200 mg BID64.4 percentage of participants
NCT01760954EndometriosisPercentage of Participants With a Response for Non-menstrual Pelvic Pain at Month 6 Based on Daily Assessment
Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and Month 6
Elagolix/Elagolix 150 mg QD67.5 percentage of participants
Elagolix/Elagolix 200 mg BID69.1 percentage of participants
Placebo/Elagolix 150 mg QD39.5 percentage of participants
Placebo/Elagolix 200 mg BID57.5 percentage of participants
NCT01931670
ELARIS EM-II
EndometriosisPercentage of Responders at Month 3 Based on Daily Assessment of Dysmenorrhea (DYS)
At Month 3 of the Treatment Period
Elagolix 150 mg QD43.4 percentage of participants
Elagolix 200 mg BID72.4 percentage of participants
Placebo22.7 percentage of participants
NCT01931670
ELARIS EM-II
EndometriosisPercentage of Responders at Month 3 Based on Daily Assessment of Non-Menstrual Pelvic Pain (NMPP)
At Month 3 of Treatment Period
Elagolix 150 mg QD49.8 percentage of participants
Elagolix 200 mg BID57.8 percentage of participants
Placebo36.5 percentage of participants
NCT02143713EndometriosisPercentage of Participants With a Response for Dysmenorrhea at Month 6 Based on Daily Assessment
Baseline (defined as baseline of Study M12-671 for participants who received elagolix in the pivotal study and baseline of the extension study M12-821 for participants who received placebo in the pivotal study) and Month 6
Elagolix/Elagolix 150 mg QD50.8 percentage of participants
Elagolix/Elagolix 200 mg BID75.9 percentage of participants
Placebo/Elagolix 150 mg QD37.0 percentage of participants
Placebo/Elagolix 200 mg BID57.1 percentage of participants
NCT02143713EndometriosisPercentage of Participants With a Response for Non-menstrual Pelvic Pain at Month 6 Based on Daily Assessment
Baseline (defined as baseline of Study M12-671 for participants who received elagolix in the pivotal study and baseline of the extension study M12-821 for participants who received placebo in the pivotal study) and Month 6
Elagolix/Elagolix 150 mg QD66.4 percentage of participants
Elagolix/Elagolix 200 mg BID67.2 percentage of participants
Placebo/Elagolix 150 mg QD27.2 percentage of participants
Placebo/Elagolix 200 mg BID32.7 percentage of participants
NCT02654054LeiomyomaPercentage of Participants Meeting the Criteria for Responder
Final Month (the last 28 days prior to and including the Reference Day), up to Month 6
Elagolix84.1 percentage of participants
Elagolix + E2/NETA68.5 percentage of participants
Placebo8.7 percentage of participants
NCT02691494LeiomyomaPercentage of Participants Meeting the Criteria for Responder
Final Month (the last 28 days prior to and including the Reference Day), up to Month 6
Elagolix76.9 percentage of participants
Elagolix + E2/NETA76.5 percentage of participants
Placebo10.5 percentage of participants
NCT02925494LeiomyomaPercentage of Participants Meeting the Criteria for Responder
From Month 0 (Baseline in Pivotal Study) to Final Month of Treatment Period (up through Month 6 in Extension Study)
Elagolix->Elagolix89.4 percentage of participants
Elagolix + E2/NETA->Elagolix + E2/NETA87.9 percentage of participants
Placebo->Elagolix85.7 percentage of participants
Placebo->Elagolix + E2/NETA66.7 percentage of participants
NCT03213457EndometriosisCo-Primary Endpoint: Percentage of Participants With a Response for Dysmenorrhea (DYS) at Months 6 and 12 Based on Daily Assessment
Month 6, Month 12
Elagolix + E2/NETA63.8 percentage of participants
Elagolix + E2/NETA62.8 percentage of participants
Placebo29.1 percentage of participants
Placebo23.7 percentage of participants
NCT03213457EndometriosisCo-Primary Endpoint: Percentage of Participants With a Response for Non-menstrual Pelvic Pain (NMPP) at Months 6 and 12 Based on Daily Assessment
Month 6, Month 12
Elagolix + E2/NETA51.3 percentage of participants
Elagolix + E2/NETA54.3 percentage of participants
Placebo42.3 percentage of participants
Placebo36.8 percentage of participants
NCT03271489LeiomyomaNumber of Participants With Adverse Events (AEs)
Baseline to 60 months
Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA)203 Participants
Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA)124 Participants
Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA)22 Participants
Placebo83 Participants
Placebo59 Participants
Placebo6 Participants

Publications by year

1987–2026: 62 publications.

1987
1
1991
1
2001
2
2002
4
2004
1
2006
3
2008
1
2011
2
2013
2
2014
2
2015
1
2017
7
2018
2
2019
5
2020
8
2021
5
2022
10
2023
2
2024
1
2026
2

Publications by indication

Endometriosis (31)

  • Efficacy and safety of eliapixant in endometriosis-associated pelvic pain: the randomized, placebo-controlled phase 2b SCHUMANN study.
    BMC Womens Health · 2024 · PMID 38890641 · NCT04614246
  • Pre-IVF treatment with a GnRH antagonist in women with endometriosis (PREGNANT): study protocol for a prospective, double-blind, placebo-controlled trial.
    BMJ Open · 2022 · PMID 35715184 · NCT04173169
  • Validation of a quantitative systems pharmacology model of calcium homeostasis using elagolix Phase 3 clinical trial data in women with endometriosis.
    Clin Transl Sci · 2022 · PMID 33963686 · NCT01620528
  • Willingness of Women with Endometriosis Planning to Undergo IVF to Participate in a Randomized Clinical Trial and the Effects of the COVID-19 Pandemic on Potential Participation.
    Reprod Sci · 2022 · PMID 34363198 · NCT04173169
  • Selectivity of the P2X3 receptor antagonist Eliapixant, and its potential use in the treatment of endometriosis.
    Purinergic Signal · 2022 · PMID 34978027 · NCT04614246

Leiomyoma (20)

  • Impact of demographic and clinical factors on elagolix plus add-back therapy effects on patient-reported nonbleeding symptoms in women with heavy menstrual bleeding and uterine fibroids: a post hoc analysis of data from two clinical trials.
    F S Rep · 2026 · PMID 39381651 · NCT02654054
  • Efficacy and safety of elagolix with add-back therapy in women with uterine fibroids and coexisting adenomyosis.
    F S Rep · 2026 · PMID 34553161 · NCT02691494
  • Low-Dose Elagolix for the Treatment of Heavy Menstrual Bleeding in Patients With Uterine Leiomyomas: A Randomized Controlled Trial.
    Obstet Gynecol · 2023 · PMID 37769311 · NCT03886220
  • Reduction of Heavy Menstrual Bleeding in Women Not Designated as Responders to Elagolix Plus Add Back Therapy for Uterine Fibroids.
    J Womens Health (Larchmt) · 2022 · PMID 34582715 · NCT02691494
  • Integrating real-world data and modeling to project changes in femoral neck bone mineral density and fracture risk in premenopausal women.
    Clin Transl Sci · 2022 · PMID 33650259 · NCT02691494

Anovulation (10)

  • Does timing matter when initiating elagolix in a natural menstrual cycle?
    F S Rep · 2022 · PMID 34553156 · NCT04060992
  • Long-Term Outcomes of Elagolix in Women With Endometriosis: Results From Two Extension Studies.
    Obstet Gynecol · 2019 · PMID 29889764 · NCT04060992
  • Elagolix (Orilissa)--an oral GnRH antagonist for endometriosis pain.
    Med Lett Drugs Ther · 2018 · PMID 30383729 · NCT04060992
  • Dose-Dependent Suppression of Gonadotropins and Ovarian Hormones by Elagolix in Healthy Premenopausal Women.
    J Clin Endocrinol Metab · 2017 · PMID 28323948 · NCT04060992
  • Gonadotropin-releasing hormone analogs: Understanding advantages and limitations.
    J Hum Reprod Sci · 2014 · PMID 25395741 · NCT04060992

Polycystic Ovary Syndrome (1)

  • Phase 2, double-blind, randomized, placebo-controlled study of the safety and efficacy of elagolix in women with polycystic ovary syndrome.
    F S Rep · 2023 · PMID 37398623 · NCT03951077

Publications by journal

Trial-results highlights

In studies evaluating Elagolix for endometriosis, primary outcomes included the percentage of participants who responded to treatment based on daily assessments of dysmenorrhea (menstrual pain) and non-menstrual pelvic pain. For dysmenorrhea at Month 3, in NCT01620528, 46.4% of participants in the Elagolix 150 mg QD arm and 75.8% in the Elagolix 200 mg BID arm were responders, compared to 19.6% in the placebo arm. Similarly, in NCT01931670, 43.4% of participants in the Elagolix 150 mg QD arm and 72.4% in the Elagolix 200 mg BID arm showed a response, versus 22.7% in the placebo arm.

For non-menstrual pelvic pain at Month 3, NCT01620528 reported 50.4% of participants in the Elagolix 150 mg QD arm and 54.5% in the Elagolix 200 mg BID arm as responders, compared to 36.5% in the placebo arm. In NCT01931670, 49.8% of participants in the Elagolix 150 mg QD arm and 57.8% in the Elagolix 200 mg BID arm responded, while 36.5% in the placebo arm responded.

Longer-term data at Month 6 for dysmenorrhea showed that in NCT01760954, 52.1% of participants continuing Elagolix 150 mg QD and 78.2% continuing Elagolix 200 mg BID responded. Among those who switched from placebo to Elagolix, 32.6% (150 mg QD) and 64.4% (200 mg BID) responded. In NCT02143713, 50.8% of participants continuing Elagolix 150 mg QD and 75.9% continuing Elagolix 200 mg BID responded. For those switching from placebo to Elagolix, 37.0% (150 mg QD) and 57.1% (200 mg BID) responded. For non-menstrual pelvic pain at Month 6, NCT01760954 reported 67.5% (Elagolix/Elagolix 150 mg QD) and 69.1% (Elagolix/Elagolix 200 mg BID) responders, with 39.5% (Placebo/Elagolix 150 mg QD) and 57.5% (Placebo/Elagolix 200 mg BID) responders. In NCT02143713, 66.4% (Elagolix/Elagolix 150 mg QD) and 67.2% (Elagolix/Elagolix 200 mg BID) responded, while 27.2% (Placebo/Elagolix 150 mg QD) and 32.7% (Placebo/Elagolix 200 mg BID) responded. All values are sourced from primary registry reporting, and individual papers should be consulted for clinical decisions.

All Elagolix publications (62)

2026 (2 papers)

  1. Impact of demographic and clinical factors on elagolix plus add-back therapy effects on patient-reported nonbleeding symptoms in women with heavy menstrual bleeding and uterine fibroids: a post hoc analysis of data from two clinical trials.
    Simon JA, Stewart EA, Jewell S, et al. · F S Rep · 2026 · Derived
    PubMed: PMID 39381651 · NCT02654054 · Leiomyoma
  2. Efficacy and safety of elagolix with add-back therapy in women with uterine fibroids and coexisting adenomyosis.
    Muneyyirci-Delale O, Archer DF, Owens CD, et al. · F S Rep · 2026 · Derived
    PubMed: PMID 34553161 · NCT02691494 · Leiomyoma

2024 (1 paper)

  1. Efficacy and safety of eliapixant in endometriosis-associated pelvic pain: the randomized, placebo-controlled phase 2b SCHUMANN study.
    Parke S, Gude K, Roth K, et al. · BMC Womens Health · 2024 · Derived
    PubMed: PMID 38890641 · NCT04614246 (SCHUMANN) · Endometriosis

2023 (2 papers)

  1. Phase 2, double-blind, randomized, placebo-controlled study of the safety and efficacy of elagolix in women with polycystic ovary syndrome.
    Snabes MC, Ng J, Li H, et al. · F S Rep · 2023 · Derived
    PubMed: PMID 37398623 · NCT03951077 · Polycystic Ovary Syndrome
  2. Low-Dose Elagolix for the Treatment of Heavy Menstrual Bleeding in Patients With Uterine Leiomyomas: A Randomized Controlled Trial.
    Brown E, Kroll R, Li H, et al. · Obstet Gynecol · 2023 · Derived
    PubMed: PMID 37769311 · NCT03886220 · Leiomyoma

2022 (10 papers)

  1. Pre-IVF treatment with a GnRH antagonist in women with endometriosis (PREGNANT): study protocol for a prospective, double-blind, placebo-controlled trial.
    Taylor H, Li HJ, Carson S, et al. · BMJ Open · 2022 · Derived
    PubMed: PMID 35715184 · NCT04173169 (PREGnant) · Endometriosis
  2. Validation of a quantitative systems pharmacology model of calcium homeostasis using elagolix Phase 3 clinical trial data in women with endometriosis.
    Stodtmann S, Nader A, Polepally AR, et al. · Clin Transl Sci · 2022 · Derived
    PubMed: PMID 33963686 · NCT01620528 (ELARIS EM-I) · Endometriosis
  3. Reduction of Heavy Menstrual Bleeding in Women Not Designated as Responders to Elagolix Plus Add Back Therapy for Uterine Fibroids.
    Stewart EA, Archer DF, Owens CD, et al. · J Womens Health (Larchmt) · 2022 · Derived
    PubMed: PMID 34582715 · NCT02691494 · Leiomyoma
  4. Willingness of Women with Endometriosis Planning to Undergo IVF to Participate in a Randomized Clinical Trial and the Effects of the COVID-19 Pandemic on Potential Participation.
    Pretzel S, Kuhn K, Pal L, et al. · Reprod Sci · 2022 · Derived
    PubMed: PMID 34363198 · NCT04173169 (PREGnant) · Endometriosis
  5. Selectivity of the P2X3 receptor antagonist Eliapixant, and its potential use in the treatment of endometriosis.
    Fletcher MC · Purinergic Signal · 2022 · Derived
    PubMed: PMID 34978027 · NCT04614246 (SCHUMANN) · Endometriosis
  6. Does timing matter when initiating elagolix in a natural menstrual cycle?
    Danis RB, Sriprasert I, Stanczyk FZ, et al. · F S Rep · 2022 · Derived
    PubMed: PMID 34553156 · NCT04060992 · Anovulation
  7. Population Pharmacokinetics of Elagolix in Combination with Low-Dose Estradiol/Norethindrone Acetate in Women with Uterine Fibroids.
    Beck D, Winzenborg I, Liu M, et al. · Clin Pharmacokinet · 2022 · Derived
    PubMed: PMID 34878624 · NCT01931670 (ELARIS EM-II) · Endometriosis
  8. Integrating real-world data and modeling to project changes in femoral neck bone mineral density and fracture risk in premenopausal women.
    Beck D, Winzenborg I, Gao W, et al. · Clin Transl Sci · 2022 · Derived
    PubMed: PMID 33650259 · NCT02691494 · Leiomyoma
  9. Predictors of response for elagolix with add-back therapy in women with heavy menstrual bleeding associated with uterine fibroids.
    Al-Hendy A, Bradley L, Owens CD, et al. · Am J Obstet Gynecol · 2022 · Derived
    PubMed: PMID 32702363 · NCT02654054 · Leiomyoma
  10. Endometriosis-Related Pain Reduction During Bleeding and Nonbleeding Days in Women Treated with Elagolix.
    Agarwal SK, Singh SS, Archer DF, et al. · J Pain Res · 2022 · Derived
    PubMed: PMID 33564263 · NCT01620528 (ELARIS EM-I) · Endometriosis

2021 (5 papers)

  1. Effect of Elagolix Exposure on Clinical Efficacy End Points in Phase III Trials in Women With Endometriosis-Associated Pain: An Application of Markov Model.
    Winzenborg I, Polepally AR, Nader A, et al. · CPT Pharmacometrics Syst Pharmacol · 2021 · Derived
    PubMed: PMID 32621325 · NCT01620528 (ELARIS EM-I) · Endometriosis
  2. Bone Mineral Density Changes Associated With Pregnancy, Lactation, and Medical Treatments in Premenopausal Women and Effects Later in Life.
    Watts NB, Binkley N, Owens CD, et al. · J Womens Health (Larchmt) · 2021 · Derived
    PubMed: PMID 34435897 · NCT03213457 · Endometriosis
  3. Responsiveness and thresholds for clinically meaningful changes in worst pain numerical rating scale for dysmenorrhea and nonmenstrual pelvic pain in women with moderate to severe endometriosis.
    Pokrzywinski RM, Soliman AM, Snabes MC, et al. · Fertil Steril · 2021 · Derived
    PubMed: PMID 33066973 · NCT01931670 (ELARIS EM-II) · Endometriosis
  4. Reductions in endometriosis-associated pain among women treated with elagolix are consistent across a range of baseline characteristics reflective of real-world patients.
    Abrao MS, Surrey E, Gordon K, et al. · BMC Womens Health · 2021 · Derived
    PubMed: PMID 34134684 · NCT01931670 (ELARIS EM-II) · Endometriosis
  5. Exposure-Safety Analyses Identify Predictors of Change in Bone Mineral Density and Support Elagolix Labeling for Endometriosis-Associated Pain.
    Abbas Suleiman A, Nader A, Winzenborg I, et al. · CPT Pharmacometrics Syst Pharmacol · 2021 · Derived
    PubMed: PMID 32945631 · NCT01620528 (ELARIS EM-I) · Endometriosis

2020 (8 papers)

  1. Elagolix for Heavy Menstrual Bleeding in Women with Uterine Fibroids.
    Schlaff WD, Ackerman RT, Al-Hendy A, et al. · N Engl J Med · 2020 · Trial result
    PubMed: PMID 31971678 · NCT04856306 (Magical) · Leiomyoma
  2. Cost-effectiveness of elagolix versus leuprolide acetate for treating moderate-to-severe endometriosis pain in the USA.
    Wang ST, Johnson SJ, Mitchell D, et al. · J Comp Eff Res · 2020 · Derived
    PubMed: PMID 30724096 · NCT01931670 (ELARIS EM-II) · Endometriosis
  3. Health-Related Quality of Life Improvements in Patients With Endometriosis Treated With Elagolix.
    Taylor HS, Soliman AM, Johns B, et al. · Obstet Gynecol · 2020 · Derived
    PubMed: PMID 32769633 · NCT01931670 (ELARIS EM-II) · Endometriosis
  4. Impact of Elagolix on Workplace and Household Productivity Among Women with Moderate to Severe Pain Associated with Endometriosis: A Pooled Analysis of Two Phase III Trials.
    Surrey ES, Soliman AM, Palac HL, et al. · Patient · 2020 · Derived
    PubMed: PMID 31654294 · NCT01620528 (ELARIS EM-I) · Endometriosis
  5. Endometriosis: advances and controversies in classification, pathogenesis, diagnosis, and treatment.
    Rolla E · F1000Res · 2020 · Derived
    PubMed: PMID 31069056 · NCT01931670 (ELARIS EM-II) · Endometriosis
  6. Impact of elagolix on work loss due to endometriosis-associated pain: estimates based on the results of two phase III clinical trials.
    Pokrzywinski RM, Soliman AM, Chen J, et al. · Fertil Steril · 2020 · Derived
    PubMed: PMID 31227284 · NCT01620528 (ELARIS EM-I) · Endometriosis
  7. Elagolix Suppresses Ovulation in a Dose-Dependent Manner: Results From a 3-Month, Randomized Study in Ovulatory Women.
    Archer DF, Ng J, Chwalisz K, et al. · J Clin Endocrinol Metab · 2020 · Derived
    PubMed: PMID 31650182 · NCT01403038 · Endometriosis
  8. Elagolix Treatment for Up to 12 Months in Women With Heavy Menstrual Bleeding and Uterine Leiomyomas.
    Simon JA, Al-Hendy A, Archer DF, et al. · Obstet Gynecol · 2020 · Background
    PubMed: PMID 32459423 · NCT02925494 · Leiomyoma

2019 (5 papers)

  1. Long-Term Outcomes of Elagolix in Women With Endometriosis: Results From Two Extension Studies.
    Surrey E, Taylor HS, Giudice L, et al. · Obstet Gynecol · 2019 · Trial result
    PubMed: PMID 29889764 · NCT04060992 · Anovulation
  2. Population Pharmacokinetics of Elagolix in Healthy Women and Women with Endometriosis.
    Winzenborg I, Nader A, Polepally AR, et al. · Clin Pharmacokinet · 2019 · Derived
    PubMed: PMID 29476499 · NCT01931670 (ELARIS EM-II) · Endometriosis
  3. Impact of elagolix treatment on fatigue experienced by women with moderate to severe pain associated with endometriosis.
    Surrey ES, Soliman AM, Agarwal SK, et al. · Fertil Steril · 2019 · Derived
    PubMed: PMID 30992150 · NCT01760954 · Endometriosis
  4. Elagolix Alone or With Add-Back Therapy in Women With Heavy Menstrual Bleeding and Uterine Leiomyomas: A Randomized Controlled Trial.
    Carr BR, Stewart EA, Archer DF, et al. · Obstet Gynecol · 2019 · Derived
    PubMed: PMID 30303923 · NCT01817530 · Leiomyoma
  5. Medical or surgical treatment before embryo transfer improves outcomes in women with abnormal endometrial BCL6 expression.
    Likes CE, Cooper LJ, Efird J, et al. · J Assist Reprod Genet · 2019 · Background
    PubMed: PMID 30610661 · NCT04039204 (EFFECT) · Endometriosis

2018 (2 papers)

  1. Elagolix (Orilissa)--an oral GnRH antagonist for endometriosis pain.
    Med Lett Drugs Ther · 2018 · Trial result
    PubMed: PMID 30383729 · NCT04060992 · Anovulation
  2. GnRH agonist administration prior to embryo transfer in freeze-all cycles of patients with endometriosis or aberrant endometrial integrin expression.
    Surrey ES, Katz-Jaffe M, Kondapalli LV, et al. · Reprod Biomed Online · 2018 · Background
    PubMed: PMID 28601378 · NCT04445025 · Endometriosis

2017 (7 papers)

  1. Treatment of Endometriosis-Associated Pain with Elagolix, an Oral GnRH Antagonist.
    Taylor HS, Giudice LC, Lessey BA, et al. · N Engl J Med · 2017 · Trial result
    PubMed: PMID 28525302 · NCT01931670 (ELARIS EM-II) · Endometriosis
  2. Dose-Dependent Suppression of Gonadotropins and Ovarian Hormones by Elagolix in Healthy Premenopausal Women.
    Ng J, Chwalisz K, Carter DC, et al. · J Clin Endocrinol Metab · 2017 · Trial result
    PubMed: PMID 28323948 · NCT04060992 · Anovulation
  3. Validation of the 4 week recall version of the Uterine Fibroid Symptom and Health-related Quality of Life (UFS-QOL) Questionnaire.
    Coyne KS, Soliman AM, Margolis MK, et al. · Curr Med Res Opin · 2017 · Derived
    PubMed: PMID 27733082 · NCT01441635 · Leiomyoma
  4. Uterine Fibroids: Diagnosis and Treatment.
    De La Cruz MS, Buchanan EM · Am Fam Physician · 2017 · Background
    PubMed: PMID 28084714 · NCT04856306 (Magical) · Leiomyoma
  5. Serum microRNAs as diagnostic markers of endometriosis: a comprehensive array-based analysis.
    Cosar E, Mamillapalli R, Ersoy GS, et al. · Fertil Steril · 2017 · Background
    PubMed: PMID 27179784 · NCT04445025 · Endometriosis
  6. Elagolix for the management of heavy menstrual bleeding associated with uterine fibroids: results from a phase 2a proof-of-concept study.
    Archer DF, Stewart EA, Jain RI, et al. · Fertil Steril · 2017 · Background
    PubMed: PMID 28579415 · NCT01441635 · Leiomyoma
  7. Endometrial BCL6 testing for the prediction of in vitro fertilization outcomes: a cohort study.
    Almquist LD, Likes CE, Stone B, et al. · Fertil Steril · 2017 · Background
    PubMed: PMID 29126613 · NCT04039204 (EFFECT) · Endometriosis

2015 (1 paper)

  1. Uterine artery embolization for symptomatic uterine fibroids.
    Gupta JK, Sinha A, Lumsden MA, et al. · Cochrane Database Syst Rev · 2015 · Background
    PubMed: PMID 25541260 · NCT04856306 (Magical) · Leiomyoma

2014 (2 papers)

  1. Gonadotropin-releasing hormone analogs: Understanding advantages and limitations.
    Kumar P, Sharma A · J Hum Reprod Sci · 2014 · Trial result
    PubMed: PMID 25395741 · NCT04060992 · Anovulation
  2. Validation of a new menstrual pictogram (superabsorbent polymer-c version) for use with ultraslim towels that contain superabsorbent polymers.
    Magnay JL, Nevatte TM, O'Brien S, et al. · Fertil Steril · 2014 · Background
    PubMed: PMID 24331833 · NCT04856306 (Magical) · Leiomyoma

2013 (2 papers)

  1. GnRH agonist versus GnRH antagonist in in vitro fertilization and embryo transfer (IVF/ET).
    Depalo R, Jayakrishan K, Garruti G, et al. · Reprod Biol Endocrinol · 2013 · Trial result
    PubMed: PMID 22500852 · NCT04060992 · Anovulation
  2. Validation of the menstrual pictogram in women with leiomyomata associated with heavy menstrual bleeding.
    Larsen L, Coyne K, Chwalisz K, et al. · Reprod Sci · 2013 · Background
    PubMed: PMID 23188490 · NCT04856306 (Magical) · Leiomyoma

2011 (2 papers)

  1. Live birth outcome with trophectoderm biopsy, blastocyst vitrification, and single-nucleotide polymorphism microarray-based comprehensive chromosome screening in infertile patients.
    Schoolcraft WB, Treff NR, Stevens JM, et al. · Fertil Steril · 2011 · Background
    PubMed: PMID 21782169 · NCT04445025 · Endometriosis
  2. Complications of uterine fibroid embolization.
    Schirf BE, Vogelzang RL, Chrisman HB, et al. · Semin Intervent Radiol · 2011 · Background
    PubMed: PMID 21326757 · NCT04856306 (Magical) · Leiomyoma

2008 (1 paper)

  1. The incidence of aberrant endometrial alphavbeta(3) vitronectin expression in a high risk infertility population: could prolonged GnRH agonist therapy play a role?
    Surrey ES, Minjarez DA, Schoolcraft WB, et al. · J Assist Reprod Genet · 2008 · Background
    PubMed: PMID 18026832 · NCT04445025 · Endometriosis

2006 (3 papers)

  1. Long-term pituitary down-regulation before in vitro fertilization (IVF) for women with endometriosis.
    Sallam HN, Garcia-Velasco JA, Dias S, et al. · Cochrane Database Syst Rev · 2006 · Background
    PubMed: PMID 16437491 · NCT04445025 · Endometriosis
  2. Role of laparoscopic treatment of endometriosis in patients with failed in vitro fertilization cycles.
    Littman E, Giudice L, Lathi R, et al. · Fertil Steril · 2006 · Background
    PubMed: PMID 16359945 · NCT04039204 (EFFECT) · Endometriosis
  3. Uterine artery embolization versus myomectomy: a multicenter comparative study.
    Goodwin SC, Bradley LD, Lipman JC, et al. · Fertil Steril · 2006 · Background
    PubMed: PMID 16412720 · NCT04856306 (Magical) · Leiomyoma

2004 (1 paper)

  1. Single blastocyst transfer: a prospective randomized trial.
    Gardner DK, Surrey E, Minjarez D, et al. · Fertil Steril · 2004 · Background
    PubMed: PMID 15037401 · NCT04445025 · Endometriosis

2002 (4 papers)

  1. Effect of prolonged gonadotropin-releasing hormone agonist therapy on the outcome of in vitro fertilization-embryo transfer in patients with endometriosis.
    Surrey ES, Silverberg KM, Surrey MW, et al. · Fertil Steril · 2002 · Trial result
    PubMed: PMID 12372443 · NCT04445025 · Endometriosis
  2. Human ovarian steroid secretion in vivo: effects of GnRH agonist versus antagonist (cetrorelix).
    Garcia-Velasco JA, Isaza V, Vidal C, et al. · Hum Reprod · 2002 · Trial result
    PubMed: PMID 11726570 · NCT04060992 · Anovulation
  3. Comparison of long-term outcomes of myomectomy and uterine artery embolization.
    Broder MS, Goodwin S, Chen G, et al. · Obstet Gynecol · 2002 · Trial result
    PubMed: PMID 12423842 · NCT04856306 (Magical) · Leiomyoma
  4. The UFS-QOL, a new disease-specific symptom and health-related quality of life questionnaire for leiomyomata.
    Spies JB, Coyne K, Guaou Guaou N, et al. · Obstet Gynecol · 2002 · Background
    PubMed: PMID 11814511 · NCT04856306 (Magical) · Leiomyoma

2001 (2 papers)

  1. Efficacy and safety of ganirelix acetate versus leuprolide acetate in women undergoing controlled ovarian hyperstimulation.
    Fluker M, Grifo J, Leader A, et al. · Fertil Steril · 2001 · Trial result
    PubMed: PMID 11163814 · NCT04060992 · Anovulation
  2. Determination of total menstrual blood loss.
    Wyatt KM, Dimmock PW, Walker TJ, et al. · Fertil Steril · 2001 · Background
    PubMed: PMID 11438330 · NCT04856306 (Magical) · Leiomyoma

1991 (1 paper)

  1. Variable ovarian response to gonadotropin-releasing hormone antagonist-induced gonadotropin deprivation during different phases of the menstrual cycle.
    Fluker MR, Marshall LA, Monroe SE, et al. · J Clin Endocrinol Metab · 1991 · Trial result
    PubMed: PMID 2005218 · NCT04060992 · Anovulation

1987 (1 paper)

  1. Therapeutic uses of gonadotropin-releasing hormone analogs.
    Andreyko JL, Marshall LA, Dumesic DA, et al. · Obstet Gynecol Surv · 1987 · Trial result
    PubMed: PMID 3543765 · NCT04060992 · Anovulation

Sources and methodology

This page summarizes published evidence for general reference and does not constitute medical advice. For clinical decisions, consult the linked primary publications and your healthcare provider. Data sourced from PubMed and the ClinicalTrials.gov / AACT database maintained by the Clinical Trials Transformation Initiative (CTTI).