Vaginal health, endometrial thickness and changes in bone markers in postmenopausal women after 6 months of treatment with ospemifene in real clinical practice

References

• Mac Bride MB, Rhodes DJ, Shuster LT. Vulvovaginal atrophy. Mayo Clin Proc. 2010;85(1):87–94. Jan
   PubMed Web of Science ®Google Scholar
• Palacios S, Cancelo Hidalgo MJ, González SP, et al. Genitourinary syndrome of menopause: recommendations from the Spanish society of obstetrics and gynecology. Prog Obstet Ginecol. 2019;62(2):141–148.
   Google Scholar
• Moreira ED, Glasser DB, Nicolosi A, et al. Sexual problems and help-seeking behaviour in adults in the United Kingdom and continental Europe. BJU Int. 2008;101(8):1005–1011.
   PubMed Web of Science ®Google Scholar
• Minkin MJ, Maamari R, Reiter S. Improved compliance and patient satisfaction with estradiol vaginal tablets in postmenopausal women previously treated with another local estrogen therapy. Int J Womens Health. 2013;5:133–139.
   PubMedGoogle Scholar
• Weissmann-Brenner A, Bayevsky T, Yoles I. Compliance to vaginal treatment-tablets versus cream: a retrospective 9 years study. Menopause. 2017;24(1):73–76. Jan
   PubMed Web of Science ®Google Scholar
• Bachmann GA, Ospemifene Study Group, Komi JO. Ospemifene study G. Ospemifene effectively treats vulvovaginal atrophy in postmenopausal women: results from a pivotal phase 3 study. Menopause. 2010;17(3):480–486.
   PubMed Web of Science ®Google Scholar
• Portman DJ, Bachmann GA, Simon JA. Ospemifene, a novel selective estrogen receptor modulator for treating dyspareunia associated with postmenopausal vulvar and vaginal atrophy. Menopause. 2013;20(6):623–630. Jun
   PubMed Web of Science ®Google Scholar
• Portman D, Palacios S, Nappi RE, et al. Ospemifene, a non-oestrogen selective oestrogen receptor modulator for the treatment of vaginal dryness associated with postmenopausal vulvar and vaginal atrophy: a randomised, placebo-controlled, phase III trial. Maturitas. 2014;78(2):91–98.
   PubMed Web of Science ®Google Scholar
• Pinkerton JV, Goldstein SR. Endometrial safety: a key hurdle for selective estrogen receptor modulators in development. Menopause. 2010;17(3):642–653.
   PubMed Web of Science ®Google Scholar
• Ibe C, Simon JA. Vulvovaginal atrophy: current and future therapies (CME). J Sex Med. 2010;7(3):1042–1050; quiz 1051.
   PubMed Web of Science ®Google Scholar
• Simon JA, Lin VH, Radovich C, et al. One-year long-term safety extension study of ospemifene for the treatment of vulvar and vaginal atrophy in postmenopausal women with a uterus. Menopause. 2013;20(4):418–427.
   PubMed Web of Science ®Google Scholar
• Constantine GD, Goldstein SR, Archer DF. Endometrial safety of ospemifene: results of the phase 2/3 clinical development program. Menopause. 2015;22(1):36–43.
   PubMed Web of Science ®Google Scholar
• Komi J, Heikkinen J, Rutanen EM, et al. Effects of ospemifene, a novel SERM, on biochemical markers of bone turnover in healthy postmenopausal women. Gynecol Endocrinol. 2004;18(3):152–158.
   PubMed Web of Science ®Google Scholar
• Komi J, Lankinen KS, DeGregorio M, et al. Effects of ospemifene and raloxifene on biochemical markers of bone turnover in postmenopausal women. J Bone Miner Metab. 2006;24(4):314–318.
   PubMed Web of Science ®Google Scholar
• Blonde L, Khunti K, Harris SB, et al. Interpretation and impact of real-world clinical data for the practicing clinician. Adv Ther. 2018;35(11):1763–1774. Nov
   PubMed Web of Science ®Google Scholar
• Pingarrón C, de Lafuente P, Ierullo AM, et al. Ospemifene in clinical practice for vulvo-vaginal atrophy: results at 3 months of follow-up of use. Gynecol Endocrinol. 2020;10:1–5.
   Google Scholar
• Bachmann G. Urogenital ageing: an old problem newly recognized. Maturitas. 1995;(Suppl 22):S1–S5.
   PubMedGoogle Scholar
• Sánchez F, Pérez Conchillo M, Borrás Valls JJ, et al. Design and validation of the questionnaire on women's sexual function (WSF). Aten Primaria. 2004;34(6):286–292.
   PubMedGoogle Scholar
• Ruiz MA, Pardo A, Rejas J, et al. Development and validation of the "treatment satisfaction with medicines questionnaire" (SATMED-Q). Value Health. 2008;11(5):913–926.
   PubMed Web of Science ®Google Scholar
• Goldstein SR, Bachmann GA, Koninckx PR, et al. Ospemifene 12-month safety and efficacy in postmenopausal women with vulvar and vaginal atrophy. Climacteric. 2014;17(2):173–182.
   PubMed Web of Science ®Google Scholar
• Simon J, Portman D, Mabey RG Jr, et al. Long-term safety of ospemifene (52-week extension) in the treatment of vulvar and vaginal atrophy in hysterectomized postmenopausal women. Maturitas. 2014;77(3):274–281.
   PubMed Web of Science ®Google Scholar
• Cui Y, Zong H, Yan H, et al. The efficacy and safety of ospemifene in treating dyspareunia associated with postmenopausal vulvar and vaginal atrophy: a systematic review and meta-analysis. J Sex Med. 2014;11(2):487–497.
   PubMed Web of Science ®Google Scholar
• Melton LJ 3rd, Chrischilles EA, Cooper C, et al. Perspective. How many women have osteoporosis? J Bone Miner Res. 1992;7(9):1005–1010.
   PubMed Web of Science ®Google Scholar
• Palacios S, Silverman SL, de Villiers TJ, et al. A 7-year randomized, placebo-controlled trial assessing the long-term efficacy and safety of bazedoxifene in postmenopausal women with osteoporosis: effects on bone density and fracture. Menopause. 2015;22(8):806–813.
   PubMed Web of Science ®Google Scholar
• Ettinger B, Black DM, Mitlak BH, et al. Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene: results from a 3-year randomized clinical trial. Multiple outcomes of raloxifene evaluation (MORE) investigators. JAMA. 1999;282(7):637–645.
   PubMed Web of Science ®Google Scholar
• Voipio SK, Komi J, Kangas L, et al. Effects of ospemifene (FC-1271a) on uterine endometrium, vaginal maturation index, and hormonal status in healthy postmenopausal women. Maturitas. 2002;43(3):207–214.
   PubMed Web of Science ®Google Scholar
• Nordstrom BL, Cai B, De Gregorio F, et al. Incidence of venous thromboembolism among postmenopausal women prescribed ospemifene, selective estrogen receptor modulators for noncancer indications, or untreated vulvar and vaginal atrophy. Menopause. 2020;27(8):864–871.
   Google Scholar