Skip to main content

Advertisement

SpringerLink
Log in

Elagolix Treatment for Endometriosis-Associated Pain: Results from a Phase 2, Randomized, Double-Blind, Placebo-Controlled Study

  • Original Article
  • Published:
Reproductive Sciences Aims and scope Submit manuscript

Abstract

This Phase 2 study evaluated the safety and efficacy of elagolix for treating endometriosis-associated pain. A total of 155 women with laparoscopically confirmed endometriosis were randomized to placebo, elagolix 150 mg, or elagolix 250 mg once daily for 12 weeks. Placebo patients were rerandomized to elagolix and elagolix patients continued their dosing assignment for 12 additional weeks; the primary efficacy measure was changed from baseline in the monthly mean numerical rating scale for pain at week 12. Monthly mean (standard error of the mean) reductions were greater with elagolix versus placebo (−1.19 ± 0.18, −1.25 ± 0.18, and −0.88 ± 0.18 for elagolix 150 mg, 250 mg, and placebo, respectively); differences were not statistically significant. Monthly mean dysmenorrhea and nonmenstrual pelvic pain scores were reduced with elagolix, with significant differences for dysmenorrhea at weeks 8 and 12 versus placebo (P <.05). Minimal bone mineral density changes were observed with elagolix treatment. In women with endometriosis-associated pain, elagolix demonstrated an acceptable efficacy and safety profile in this Phase 2 study.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. Carr BR. Williams gynecology. In: Schorge JO, Schaffer JI, Halvorson LM, Hoffman B, Bradshaw KD, Cunningham FG, eds. Endometriosis. Chapter 10. New York, NY: McGraw-Hill; 2008.

    Google Scholar 

  2. Chapron C, Fauconnier A, Dubuisson JB, Barakat H, Vieira M, Breart G. Deep infiltrating endometriosis: relation between severity of dysmenorrhoea and extent of disease. Hum Reprod. 2003;18(4):760–766.

    Article  Google Scholar 

  3. Vercellini P, Fedele L, Aimi G, Pietropaolo G, Consonni D, Crosignani PG. Association between endometriosis stage, lesion type, patient characteristics and severity of pelvic pain symptoms: a multivariate analysis of over 1000 patients. Hum Reprod. 2007;22(1):266–271.

    Article  CAS  Google Scholar 

  4. Vercellini P, Trespidi L, De Giorgi O, Cortesi I, Parazzini F, Crosignani PG. Endometriosis and pelvic pain: relation to disease stage and localization. Fertil Steril. 1996;65(2):299–304.

    Article  CAS  Google Scholar 

  5. ACOG Committee on Practice Bulletins—Gynecology. ACOG Practice bulletin No. 51. chronic pelvic pain. Obstet Gynecol. 2004;103(3):589–605.

    Google Scholar 

  6. Practice Committee of American Society for Reproductive Medicine. Treatment of pelvic pain associated with endometriosis. Fertil Steril. 2008;90(suppl 5):S260-S269.

    Google Scholar 

  7. Evans S, Moalem-Taylor G, Tracey DJ. Pain and endometriosis. Pain. 2007;132 (suppl 1):S22-S25.

    Google Scholar 

  8. Greene R, Stratton P, Cleary SD, Ballweg ML, Sinaii N. Diagnostic experience among 4,334 women reporting surgically diagnosed endometriosis. Fertil Steril. 2009;91(1):32–39.

    Article  Google Scholar 

  9. Kennedy S, Bergqvist A, Chapron C, et al. ESHRE guideline for the diagnosis and treatment of endometriosis. Hum Reprod. 2005;20(10):2698–2704.

    Article  Google Scholar 

  10. Bulun SE, Cheng YH, Pavone ME, et al. Estrogen receptor-beta, estrogen receptor-alpha, and progesterone resistance in endometriosis. Semin Reprod Med. 2010;28(1):36–43.

    Article  CAS  Google Scholar 

  11. Crosignani PG, Luciano A, Ray A, Bergqvist A. Subcutaneous depot medroxyprogesterone acetate versus leuprolide acetate in the treatment of endometriosis-associated pain. Hum Reprod. 2006;21(1):248–256.

    Article  CAS  Google Scholar 

  12. Schlaff WD, Carson SA, Luciano A, Ross D, Bergqvist A. Subcutaneous injection of depot medroxyprogesterone acetate compared with leuprolide acetate in the treatment of endometriosis-associated pain. Fertil Steril. 2006;85(2):314–325.

    Article  CAS  Google Scholar 

  13. Vercellini P, Fedele L, Pietropaolo G, Frontino G, Somigliana E, Crosignani PG. Progestogens for endometriosis: forward to the past. Hum Reprod Update. 2003;9(4):387–396.

    Article  CAS  Google Scholar 

  14. Batzer FR. GnRH analogs: options for endometriosis-associated pain treatment. J Minim Invasive Gynecol. 2006;13(6):539–545.

    Article  Google Scholar 

  15. Olive DL. Gonadotropin-releasing hormone agonists for endometriosis. N Engl J Med. 2008;359(11):1136–1142.

    Article  CAS  Google Scholar 

  16. Surrey ES. Gonadotropin-releasing hormone agonist and add-back therapy: what do the data show? Curr Opin Obstet Gynecol. 2010;22(4):283–288.

    Article  Google Scholar 

  17. Fuldeore MJ, Marx SE, Chwalisz K, Smeeding JE, Brook RA. Add-back therapy use and its impact on LA persistence in patients with endometriosis. Curr Med Res Opin. 2010;26(3):729–736.

    Article  CAS  Google Scholar 

  18. Guo SW. Recurrence of endometriosis and its control. Hum Reprod Update. 2009;15(4):441–461.

    Article  Google Scholar 

  19. Tandoi I, Somigliana E, Riparini J, Ronzoni S, Vigano P, Candiani M. High rate of endometriosis recurrence in young women. J Pediatr Adolesc Gynecol. 2011;24(6):376–379.

    Article  Google Scholar 

  20. International conference on harmonisation of technical requirements for registation of pharmaceuticals for human use. Good Clinical Practice. http://ichgcp.net/. Accessed June 28, 2011.

    Google Scholar 

  21. Biberoglu KO, Behrman SJ. Dosage aspects of danazol therapy in endometriosis: short-term and long-term effectiveness. Am J Obstet Gynecol. 1981;139(6):645–654.

    Article  CAS  Google Scholar 

  22. Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole RM. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001;94(2):149–158.

    Article  Google Scholar 

  23. Jones G, Jenkinson C, Kennedy S. Development of the short form endometriosis health profile questionnaire: the EHP-5. Qual Life Res. 2004;13(3):695–704.

    Article  Google Scholar 

  24. Struthers RS, Xie Q, Sullivan SK, et al. Pharmacological characterization of a novel nonpeptide antagonist of the human gonadotropin-releasing hormone receptor, NBI-42902. Endocrinology. 2007;148(2):857–867.

    Article  CAS  Google Scholar 

  25. Matsuo H. Prediction of the change in bone mineral density induced by gonadotropin-releasing hormone agonist treatment for endometriosis. Fertil Steril. 2004;81(1):149–153.

    Article  CAS  Google Scholar 

  26. Uemura T, Mohri J, Osada H, Suzuki N, Katagiri N, Minaguchi H. Effect of gonadotropin-releasing hormone agonist on the bone mineral density of patients with endometriosis. Fertil Steril. 1994;62(2):246–250.

    Article  CAS  Google Scholar 

  27. Carr B, Chwalisz K, Jimenez R, Burke J, Jiang P, O’Brien C. A novel oral GnRH antagonist, elagolix, is effective for reducing endometriosis-associated pelvic pain: results of a 24-week randomized study. Fertil Steril. 2011;96(3):S45.

    Article  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Department of Obstetrics and Gynecology, Georgia Regents University, 1120 15th St., Augusta, GA 30912, BA-7300, USA

    Michael P. Diamond MD

  2. Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, TX, USA

    Bruce Carr MD

  3. Institute for the Study and Treatment of Endometriosis, Oak Brook, IL, USA

    W. Paul Dmowski MD

  4. Medical Center for Clinical Research, San Diego, CA, USA

    William Koltun MD

  5. Neurocrine Biosciences Inc, San Diego, CA, USA

    Chris O’Brien MD, Joshua Burke MS & Roland Jimenez BS

  6. AbbVie Inc, North Chicago, IL, USA

    Ping Jiang MS, Elizabeth Garner MD, MPH & Kristof Chwalisz MD, PhD

Authors
  1. Michael P. Diamond MD
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Bruce Carr MD
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. W. Paul Dmowski MD
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. William Koltun MD
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Chris O’Brien MD
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Ping Jiang MS
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Joshua Burke MS
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Roland Jimenez BS
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. Elizabeth Garner MD, MPH
    View author publications

    You can also search for this author in PubMed Google Scholar

  10. Kristof Chwalisz MD, PhD
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Michael P. Diamond MD.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Diamond, M.P., Carr, B., Dmowski, W.P. et al. Elagolix Treatment for Endometriosis-Associated Pain: Results from a Phase 2, Randomized, Double-Blind, Placebo-Controlled Study. Reprod. Sci. 21, 363–371 (2014). https://doi.org/10.1177/1933719113497292

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1177/1933719113497292

Keywords

Search

Navigation