Repeated two cycles of ulipristal acetate treatment improve the quality of life in premenopausal women with heavy menstrual bleeding dependent on uterine myomas, without impairment of bone health

References

• Gokyildiz S, Aslan E, Beji NK, Mecdi M. The effects of menorrhagia on women’s quality of life: a case-control study. ISRN Obstet Gynecol. 2013;2013:918179.
   PubMedGoogle Scholar
• Zimmermann A, Bernuit D, Gerlinger C, et al. Prevalence, symptoms and management of uterine fibroids: an international internet-based survey of 21,746 women. BMC Womens Health. 2012;12:6.
   PubMed Web of Science ®Google Scholar
• Stewart EA. Clinical practice. Uterine fibroids. N Engl J Med. 2015;372:1646–1655.
   PubMed Web of Science ®Google Scholar
• Melis GB, Neri M, Piras B, et al. Vilaprisan for treating uterine fibroids. Expert Opin Investig Drugs. 2018;27:497–505.
   PubMed Web of Science ®Google Scholar
• Mais V, Ajossa S, Guerriero S, et al. Laparoscopic versus abdominal myomectomy: a prospective, randomized trial to evaluate benefits in early outcome. Am J Obstet Gynecol. 1996;174:654–658.
   PubMed Web of Science ®Google Scholar
• Gupta JK, Sinha A, Lumsden MA, Hickey M. Uterine artery embolization for symptomatic uterine fibroids. Cochrane Database Syst Rev. 2014;CD005073.
   PubMed Web of Science ®Google Scholar
• Lim JH, Chung DJ, Lim YT, et al. High-intensity focused ultrasound treatment of abnormal vaginal bleeding secondary to uterine myoma. J Ultrasound Med. 2011;30:397–401.
   PubMed Web of Science ®Google Scholar
• Adamson GD. Treatment of uterine fibroids: current findings with gonadotropin-releasing hormone agonists. Am J Obstet Gynecol. 1992;166:746–751.
   PubMed Web of Science ®Google Scholar
• Duhan N. Advances in management of uterine myomas. Front Biosci (Elite Ed). 2013;5:12–22.
   PubMedGoogle Scholar
• Szczurowicz A, Wydra D. GnRH analogs in treating uterine leiomyomata and endometriosis. Clin Exp Obstet Gynecol. 1996;23:214–219.
   PubMedGoogle Scholar
• Paoletti AM, Serra GG, Cagnacci A, et al. Spontaneous reversibility of bone loss induced by gonadotropin-releasing hormone analog treatment. Fertil Steril. 1996;65:707–710.
   PubMed Web of Science ®Google Scholar
• Kawaguchi K, Fujii S, Konishi I, et al. Immunohistochemical analysis of oestrogen receptors, progesterone receptors and Ki-67 in leiomyoma and myometrium during the menstrual cycle and pregnancy. Virchows Arch A Pathol Anat Histopathol. 1991;419:309–315.
   PubMedGoogle Scholar
• Maruo T, Ohara N, Wang J, Matsuo H. Sex steroidal regulation of uterine leiomyoma growth and apoptosis. Hum Reprod Update. 2004;10:207–220.
   PubMed Web of Science ®Google Scholar
• Murphy AA, Kettel LM, Morales AJ, et al. Regression of uterine leiomyomata in response to the antiprogesterone RU 486. J Clin Endocrinol Metab. 1993;76:513–517.
   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;8:901–908.
   PubMed Web of Science ®Google Scholar
• Levens ED, Potlog-Nahari C, Armstrong AY, et al. CDB-2914 for ulipristal acetate uterine leiomyomata treatment: a randomized controlled trial. Obstet Gynecol. 2008;111:1129–1136.
   PubMed Web of Science ®Google Scholar
• Nieman LK, Blocker W, Nansel T, et al. Efficacy and tolerability of CDB-2914 treatment for symptomatic uterine fibroids: a randomized, double-blind, placebo-controlled, phase IIb study. Fertil Steril. 2011;95:767–772.
   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;366:409–420.
   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;366:421–432.
   PubMed Web of Science ®Google Scholar
• Chabbert-Buffet N, Pintiaux-Kairis A, Bouchard P. on behalf of the 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.
   PubMed Web of Science ®Google Scholar
• Donnez J, Vazquez F, Tomaszewski J, et al. Long-term treatment of uterine fibroids with ulipristal acetate*. Fertil Steril. 2014;101:1565–1573.
   PubMed Web of Science ®Google Scholar
• Donnez J, Hudecek R, Donnez O, et al. Efficacy and safety of repeated use of ulipristal acetate in uterine fibroids. Fertil Steril. 2015;103:519–527.
   PubMed Web of Science ®Google Scholar
• European Medicines Agency. Assessment report. Esmya International non-proprietary name: ULIPRISTAL. 23 April 2015. Budapest, Hungary: Esmya; 2015;1–74
   Google Scholar
• European Medicines Agency. PRAC recommends new measures to minimise risk of rare but serious liver injury with Esmya for fibroids. Budapest, Hungary: Esmya; 2018 Press release 18/05/2018.
   Google Scholar
• Warner PE, Critchley HO, Lumsden MA, et al. Menorrhagia I: measured blood loss, clinical features, and outcome in women with heavy periods: a survey with follow-up data. Am J Obstet Gynecol. 2004;190:1216–1223.
   PubMed Web of Science ®Google Scholar
• Apolone G, Mosconi P. The Italian SF-36 health survey: translation, validation and norming. J Clin Epidemiol. 1998;51:1025–1036.
   PubMed Web of Science ®Google Scholar
• Sherbourne C. Free online SF-36 Calculator orthotoolkit. Available from: http://orthotoolkit.com/sf-36/
   Google Scholar
• Freeman AA, Rye DB. The molecular basis of restless legs syndrome. Curr Opin Neurobiol. 2013;23:895–900.
   PubMed Web of Science ®Google Scholar
• Saggese G, Bertelloni S, Baroncelli GI, et al. Bone loss during gonadotropin-releasing hormone agonist treatment in girls with true precocious puberty is not due to an impairment of calcitonin secretion. J Endocrinol Invest. 1991;14:231–236.
   PubMed Web of Science ®Google Scholar
• Vasikaran SD. Utility of biochemical markers of bone turnover and bone mineral density in management of osteoporosis. Crit Rev Clin Lab Sci. 2008;45:221–258.
   PubMed Web of Science ®Google Scholar
• Bruyere O, Collette J, Delmas P, et al. Interest of biochemical markers of bone turnover for long-term prediction of new vertebral fracture in postmenopausal osteoporotic women. Maturitas. 2003;44:259–265.
   PubMed Web of Science ®Google Scholar
• Burgeson RE. New collagens, new concepts. Annu Rev Cell Biol. 1988;4:551–577.
   PubMedGoogle Scholar
• Bonde M, Qvist P, Fledelius C, et al. Immunoassay for quantifying type I collagen degradation products in urine evaluated. Clin Chem. 1994;40:2022–2025.
   PubMed Web of Science ®Google Scholar
• Yavropoulou MP, Yovos JG. Osteoclastogenesis-current knowledge and future perspectives. J Musculoskelet Neuronal Interact. 2008;8:204–216.
   PubMedGoogle Scholar
• Nagy V, Penninger JM. The RANKL-RANK story. Gerontology. 2015;61:534–542.
   PubMed Web of Science ®Google Scholar
• Lacey DL, Timms E, Tan HL, et al. Osteoprotegerin ligand is a cytokine that regulates osteoclast differentiation and activation. Cell. 1998;93:165–176.
   PubMed Web of Science ®Google Scholar
• Gundberg CM, Looker AC, Nieman SD, et al. Patterns of osteocalcin and bone specific alkaline phosphatase by age, gender, and race or ethnicity. Bone. 2002;31:703–708.
   PubMed Web of Science ®Google Scholar
• Malik P, Gasser RW, Moncayo R, et al. Markers of bone resorption and formation during abstinence in male alcoholic patients. Alcohol Clin Exp Res. 2012;36:2059–2064.
   PubMed Web of Science ®Google Scholar