Drug safety evaluation of ulipristal acetate in the treatment of uterine fibroids

Bibliography

• Hoellen F, Griesinger G, Bohlmann MK. Therapeutic drugs in the treatment of symptomatic uterine fibroids. Expert Opin Pharmacother 2013;14:2079-85
   PubMed Web of Science ®Google Scholar
• Melis GB, Piras B, Marotto MF, et al. Pharmacokinetic evaluation of ulipristal acetate for uterine leiomyoma treatment. Expert Opin Drug Metab Toxicol 2012;8:901-8
   PubMed Web of Science ®Google Scholar
• Talaulikar VS, Manyonda I. Progesterone and progesterone receptor modulators in the management of symptomatic uterine fibroids. Eur J Obstet Gynecol Reprod Biol 2012;165:135-40
   PubMed Web of Science ®Google Scholar
• McLaren JS, Morris E, Rymer J. Gonadotrophin receptor hormone analogues in combination with add-back therapy: an update. Menopause Int 2012;18(2):68-72
   PubMedGoogle Scholar
• DiVasta AD, Laufer MR. The use of gonadotropin releasing hormone analogues in adolescent and young patients with endometriosis. Curr Opin Obstet Gynecol 2013;25:287-92
   PubMed Web of Science ®Google Scholar
• Bouchard P, Chabbert-Buffet N, Fauser BC. Selective progesterone receptor modulators in reproductive medicine: pharmacology, clinical efficacy and safety. Fertil Steril 2011;96:1175-89
   PubMed Web of Science ®Google Scholar
• Luo X, Yin P, Coon V JS, et al. The selective progesterone receptor modulator CDB4124 inhibits proliferation and induces apoptosis in uterine leiomyoma cells. Fertil Steril 2010;93:2668-73
   PubMed Web of Science ®Google Scholar
• Spitz IM. Clinical utility of progesterone receptor modulators and their effect on the endometrium. Curr Opin Obstet Gynecol 2009;21:318-24
   PubMed Web of Science ®Google Scholar
• McKeage K, Croxtakk JD. Uliprista acetate: a review of its use in emergency contraception. Drugs 2011;71:935-45
   PubMed Web of Science ®Google Scholar
• Attardi BJ, Burgenson J, Hild SA, Reel JR. In vitro antiprogestational/antiglucocorticoid activity and progestin and glucocorticoid receptor binding of the putative metabolites and synthetic derivatives of CDB-2914, CDB-4124, and mifepristone. J Steroid Biochem Mol Biol 2004;88:277-88
   PubMed Web of Science ®Google Scholar
• Maruo T, Ohara N, Yoshida S, et al. Lessons learned from the preclinical drug discovery of asoprisnil and ulipristal for non-surgical treatment of uterine leiomyomas. Expert Opin Drug Discov 2011;6:897-911
   PubMed Web of Science ®Google Scholar
• Xu Q, Ohara N, Chen W, et al. Progesterone receptor modulator CDB-2914 down-regulates vascular endothelial growth factor, adrenomedullin and their receptors and modulates progesterone receptor content in cultured human uterine leiomyoma cells. Hum Reprod 2006;21:2408-16
   PubMed Web of Science ®Google Scholar
• Hague S, Zhang L, Oehler MK, et al. Expression of the hypoxically regulated angiogenic factor adrenomedullin correlates with uterine leiomyoma vascular density. Clin Cancer Res 2000;6:2808-1467
   PubMed Web of Science ®Google Scholar
• Gentry CC, Okolo SO, Te Fong LFW, et al. Quantification of vascular endothelial growth factor-A in leiomyomas and adjacent myometrium. Clin Sci 2001;101:691-5
   PubMed Web of Science ®Google Scholar
• Brown LF, Detmar M, Tognazzi K, et al. Uterine smooth muscle cells express functional receptors (flt-1 and KDR) for vascular permeability factor/vascular endothelial growth factor. Lab Invest 1997;76:245-55
   PubMed Web of Science ®Google Scholar
• Gainer EE, Ulmann A. Pharmacologic properties of CDB(VA)-2914. Steroids 2003;68:1005-11
   PubMed Web of Science ®Google Scholar
• Electronic Medicines Compendium. Esmya 5 mg tablets (Ulipristal acetate) [online]. Available from: http://www.medicines.org.uk/ECM/medicine/26068/SPC/Esmya+5+mg+Tablets+(ulipristal+acetate) [Accessed 7 March 2012]
   Google Scholar
• Blithe DL, Nieman LK, Blye RP, et al. Development of the selective progesterone receptor modulator CDB-2914 for clinical indications. Steroids 2003;68:1013-17
   PubMed Web of Science ®Google Scholar
• Larner JM, Reel JR, Blye RP. Circulating concentrations of the antiprogestins CDB-2914 and mifepristone in the female rhesus monkey following various routes of administration. Hum Reprod 2000;15:1100-6
   PubMed Web of Science ®Google Scholar
• Levens ED, Potlog-Nahari C, Armstrong AY, et al. CDB-2914 for uterine leiomyomata treatment: a randomized controlled trial. Obstet Gynecol 2008;111:1129-36
   PubMed Web of Science ®Google Scholar
• Nieman LK, Blocker W, Nansel T, et al. Efficacy and tolerability of CDB-2914 treatment for symptomatic uterne fibroids: a randomized, double-blind, placebo-controlled phase IIb study. Fertil Steril 2011;95:767-72
   PubMed Web of Science ®Google Scholar
• Donnez J, Tatarchuk TF, Bouchard P, et al. Ulipristal acetate versus placebo for fibroid treatment before surgery. N Engl J Med 2012;366:409-20
   PubMed Web of Science ®Google Scholar
• Donnez J, Tomaszewski J, Vázquez F, et al. Ulipristal acetate versus leuprolide acetate for uterine fibroids. N Engl J Med 2012;366:421-32
   PubMed Web of Science ®Google Scholar
• Donnez J, Vázquez F, Tomaszewski J, PEARL III and PEARL III Extension Study Group. Long-term treatment of uterine fibroids with ulipristal acetate. Fertil Steril 2014;101:1565-73
   PubMed Web of Science ®Google Scholar
• Eisinger SH, Meldrum S, Fiscella K, et al. Low-dose mifepristone for uterine leiomyomata. Obstet Gynecol 2003;101:243-50
   PubMed Web of Science ®Google Scholar
• Eisinger SH, Bonfiglio T, Fiscella K, et al. Twelve-month safety and efficacy of low-dose mifepristone for uterine myomas. J Minim Invasive Gynecol 2005;12:227-33
   PubMed Web of Science ®Google Scholar
• Mutter GL, Bergeron C, Deligdisch L, et al. The spectrum of endometrial pathology induced by progesterone receptor modulators. Mod Pathol 2008;21:591-8
   PubMed Web of Science ®Google Scholar
• Horne FM, Blithe DL. Progesterone receptor modulators and the endometrium: changes and consequences. Hum Reprod Update 2007;13:567-80
   PubMed Web of Science ®Google Scholar
• Williams AR, Bergeron C, Barlow DH, Ferenczy A. Endometrial morphology after treatment of uterine fibroids with the selective progesterone receptor modulator, ulipristal acetate. Int J Gynecol Pathol 2012;6:556-69
   Google Scholar
• Chabbert-Buffet N, Pintiaux-Kairis A, Bouchard P; VA2914 Study Group. Effects of the progesterone receptor modulator VA2914 in a continuous low dose on the hypothalamic-pituitary-ovarian axis and endometrium in normal women: a prospective, randomized, placebo-controlled trial. J Clin Endocrinol Metab 2007;92:3582-9
   PubMed Web of Science ®Google Scholar
• Segal TR, Zarek SM, Mumford SL, et al. Radiographic and histopathologic endometrial characteristics of women undergoing treatment with ulipristal acetate (UPA). Fertil Steril 2014;102(Suppl):286
   Google Scholar
• Luyckx M, Squifflet JL, Jadoul P, et al. First series of 18 pregnancies after ulipristal acetate treatment for uterine fibroids. Fertil Steril 2014;102:1404-9
   PubMed Web of Science ®Google Scholar
• Communal L, Vilasco M, Hugon-Rodin J, et al. Ulipristal acetate does not impact human normal breast tissue. Hum Reprod 2012;9:2785-98
   Google Scholar
• Li HW, Liao SB, Yeung WS, et al. Ulipristal acetate resembles mifepristone in modulating human Fallopian tube function. Hum Reprod 2014;29:2156-62
   PubMed Web of Science ®Google Scholar
• Tarantal AF, Hendrickx AG, Matlin SA, et al. Effects of two antiprogestins on early pregnancy in the long-tailed macaque (Macaca fascicularis). Contraception 1996;54:107-15
   PubMed Web of Science ®Google Scholar
• Hild SA, Reel JR, Hoffman LH, Blye RP. CDB-2914: anti-progestational/anti-glucocorticoid profile and post-coital anti-fertility activity in rats and rabbits. Hum Reprod 2000;15:822-9
   PubMed Web of Science ®Google Scholar
• Glasier A. The rationale for use of Ulipristal Acetate as first line in emergency contraception: biological and clinical evidence. Gynecol Endocrinol 2014;30:688-90
   PubMed Web of Science ®Google Scholar
• Levy DP, Jager M, Kapp N, Abitbol JL. Ulipristal acetate for emergency contraception: postmarketing experience after use by more than 1 million women. Contraception 2014;89:431-3
   PubMed Web of Science ®Google Scholar
• Munuce MJ, Zumoffen C, Cicaré J, et al. Effect of exposure to ulipristal acetate on sperm function. Eur J Contracept Reprod Health Care 2012;17:428-37
   PubMed Web of Science ®Google Scholar
• Munuce MJ, Cicaré J, Zumoffen C, et al. Effects of ulipristal acetate on sperm DNA fragmentation during in vitro incubation. Eur J Contracept Reprod Health Care 2013;18:355-63
   PubMed Web of Science ®Google Scholar
• Salcedo J, Rodriguez MI, Curtis KM, Kapp N. When can a woman resume or initiate contraception after taking emergency contraceptive pills? A systematic review. Contraception 2013;87:602-4
   PubMed Web of Science ®Google Scholar
• Lethaby A, Vollenhoven B, Sowter M. Pre-operative GnRH analogue therapy before hysterectomy or myomectomy for uterine fibroids. Cochrane Database Syst Rev 2001(2):CD000547
   Google Scholar
• Chen I, Motan T, Kiddoo D. Gonadotropin-releasing hormone agonist in laparoscopic myomectomy: systematic review and meta-analysis of randomized controlled trials. J Minim Invasive Gynecol 2011;18:303-9
   PubMed Web of Science ®Google Scholar
• Leone Roberti Maggiore U, Scala C, Remorgida V, et al. Triptorelin for the treatment of endometriosis. Expert Opin Pharmacother 2014;15:1153-79
   PubMed Web of Science ®Google Scholar
• Leone Roberti Maggiore U, Scala C, Venturini PL, Ferrero S. Preoperative treatment with letrozole in patients undergoing laparoscopic myomectomy of large uterine myomas: a prospective non-randomized study. Eur J Obstet Gynecol Reprod Biol 2014;181:157-62
   PubMed Web of Science ®Google Scholar
• Ferrero S, Gillott DJ, Venturini PL, Remorgida V. Use of aromatase inhibitors to treat endometriosis-related pain symptoms: a systematic review. Reprod Biol Endocrinol 2011;9:89
   PubMed Web of Science ®Google Scholar
• Bizzarri N, Ghirardi V, Remorgida V, et al. Triptorelin, letrozole and ulipristal acetate treatment before hysteroscopic resection of large myomas: prospective comparative study. J Minim Invasive Gynecol 2014;6:S22
   Google Scholar