Elagolix, an oral GnRH antagonist for endometriosisassociated pain: A randomized controlled study

Journal of Endometriosis and Pelvic Pain Disorders

Volumn 5, Issue 3, 2013, Pages 105-115

  Carr, Bruce ^a   Giudice, Linda ^b   Dmowski, W Paul ^c   O'Brien, Chris ^d   Jiang, Ping ^e   Burke, Joshua ^d   Jimenez, Roland ^d   Hass, Steven ^e   Fuldeore, Mahesh ^e   Chwalisz, Kristof ^e  

^a UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

^c Institute for the Studies and Treatment of Endometriosis   (United States)

^d NEUROCRINE BIOSCIENCES INC   (United States)

^e ABBVIE INC   (United States)

Author keywords

Elagolix; Endometriosis; GnRH antagonists; Pelvic pain

Indexed keywords

ANALGESIC AGENT; ELAGOLIX; PLACEBO;

ADULT; ARTICLE; CONTROLLED STUDY; DISEASE ASSOCIATION; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSMENORRHEA; DYSPAREUNIA; ENDOMETRIOSIS; FEMALE; FOLLOW UP; HEADACHE; HOT FLUSH; HUMAN; MAJOR CLINICAL STUDY; MULTICENTER STUDY; NAUSEA; OPEN STUDY; OUTCOME ASSESSMENT; PAIN; PAIN ASSESSMENT; PELVIC PAIN; PHASE 2 CLINICAL TRIAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SCORING SYSTEM; SINUSITIS; UPPER RESPIRATORY TRACT INFECTION;

EID: 84884915358     PISSN: 22840265     EISSN: 22840273     Source Type: Journal    
DOI: 10.5301/je.5000157     Document Type: Article

References (26)

1. Carr BR, ed. Endometriosis. In: Hoffman BL, Schorge JO, Schaffer JI, et al., eds. Williams gynecology. 2nd ed. Chap. 10. New York: McGraw-Hill; 2008.
2. ACOG Committee on Practice Bulletins-Gynecology. ACOG practice bulletin no. 51: chronic pelvic pain. Obstet Gynecol. 2004; 103(3): 589-605.
3. Practice Committee of American Society for Reproductive Medicine. Treatment of pelvic pain associated with endometriosis. Fertil Steril. 2008; 90(5)(Suppl): S260-S269.
4. Gao X, Yeh YC, Outley J, Simon J, Botteman M, Spalding J. Health-related quality of life burden of women with endometriosis: a literature review. Curr Med Res Opin. 2006; 22(9): 1787-1797.
5. Fourquet J, Báez L, Figueroa M, Iriarte RI, Flores I. Quantification of the impact of endometriosis symptoms on healthrelated quality of life and work productivity. Fertil Steril. 2011; 96(1): 107-112.
6. Nnoaham KE, Hummelshoj L, Webster P, et al; World Endometriosis Research Foundation Global Study of Women's Health Consortium. Impact of endometriosis on quality of life and work productivity: a multicenter study across ten countries. Fertil Steril. 2011; 96(2): 366, e8.
7. Batzer FR. GnRH analogs: options for endometriosisassociated pain treatment. J Minim Invasive Gynecol. 2006; 13(6): 539-545.
8. Olive DL. Gonadotropin-releasing hormone agonists for endometriosis. N Engl J Med. 2008; 359(11): 1136-1142.
9. Surrey ES. Gonadotropin-releasing hormone agonist and add-back therapy: what do the data show? Curr Opin Obstet Gynecol. 2010; 22(4): 283-288
10. 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.
11. 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.
12. Struthers RS, Nicholls AJ, Grundy J, et al. Suppression of gonadotropins and estradiol in premenopausal women by oral administration of the nonpeptide gonadotropin-releasing hormone antagonist elagolix. J Clin Endocrinol Metab. 2009; 94(2): 545-551.
13. Imani R, Thai-Cuarto D, Jimenez R, Burke J, Kroll R, O'Brien C. Petal study: safety, tolerability and effectiveness of elagolix, an oral GnRH antagonist for endometriosis. Fertil Steril. 2009; 92(3): S111-S112.
14. Dlugi AM, Miller JD, Knittle J; Lupron Study Group. Lupron depot (leuprolide acetate for depot suspension) in the treatment of endometriosis: a randomized, placebocontrolled, double-blind study. Fertil Steril. 1990; 54(3): 419-427.
15. 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.
16. Williams DA, Gendreau M, Hufford MR, Groner K, Gracely RH, Clauw DJ. Pain assessment in patients with fibromyalgia syndrome: a consideration of methods for clinical trials. Clin J Pain. 2004; 20(5): 348-356.
17. Giske L, Sandvik L, Røe C. Comparison of daily and weekly retrospectively reported pain intensity in patients with localized and generalized musculoskeletal pain. Eur J Pain. 2010; 14(9): 959-965.
18. US Department of Health and Human Services Food and Drug Administration. Guidance for industry patient-reported outcome measures: use in medical product development to support labeling claims. 2009. Available at: http://www. ispor. org/workpaper/FDA%20PRO%20Guidance. pdf.
19. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Good clinical practice. Available at: http://ichgcp. net/. Accessed June 28, 2011.
20. 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.
21. 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.
22. Hrobjartsson A, Gotzsche PC. Placebo interventions for all clinical conditions. Cochrane Database Syst Rev. 2010; CD003974.
23. 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.
24. 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.
25. Arias RD, Jain JK, Brucker C, Ross D, Ray A. Changes in bleeding patterns with depot medroxyprogesterone acetate subcutaneous injection 104 mg. Contraception. 2006; 74(3): 234-238.
26. Surrey ES, Hornstein MD. Prolonged GnRH agonist and add-back therapy for symptomatic endometriosis: longterm follow-up. Obstet Gynecol. 2002; 99(5 Pt 1): 709-719.