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Volumn 17, Issue 2, 2014, Pages 173-182

Ospemifene 12-month safety and efficacy in postmenopausal women with vulvar and vaginal atrophy

Author keywords

Dyspareunia; Efficacy; Endometrial Safety; Maturation Index; Safety; Vaginal Effects

Indexed keywords

ESTRADIOL; FOLLITROPIN; GESTAGEN; HIGH DENSITY LIPOPROTEIN; LOW DENSITY LIPOPROTEIN; LUTEINIZING HORMONE; OSPEMIFENE; PLACEBO; SEX HORMONE BINDING GLOBULIN; TAMOXIFEN;

EID: 84896373301     PISSN: 13697137     EISSN: 14730804     Source Type: Journal    
DOI: 10.3109/13697137.2013.834493     Document Type: Article
Times cited : (105)

References (48)
  • 1
    • 0034658676 scopus 로고    scopus 로고
    • Diagnosis and treatment of atrophic vaginitis
    • Bachmann GA, Nevadunsky NS. Diagnosis and treatment of atrophic vaginitis. Am Fam Physician 2000; 61: 3090-6 (Pubitemid 30347020)
    • (2000) American Family Physician , vol.61 , Issue.10 , pp. 3090-3096
    • Bachmann, G.A.1    Nevadunsky, N.S.2
  • 2
    • 69649108864 scopus 로고    scopus 로고
    • The role of local vaginal estrogen for treatment of vaginal atrophy in postmenopausal women: 2007 position statement of the North American Menopause Society
    • North American Menopause Society
    • North American Menopause Society. The role of local vaginal estrogen for treatment of vaginal atrophy in postmenopausal women: 2007 position statement of The North American Menopause Society. Menopause 2007; 14: 355-69
    • (2007) Menopause , vol.14 , pp. 355-369
  • 3
    • 68349155731 scopus 로고    scopus 로고
    • Prevalence and impact of vaginal symptoms among postmenopausal women
    • Santoro N, Komi J. Prevalence and impact of vaginal symptoms among postmenopausal women. J Sex Med 2009; 6: 2133-42
    • (2009) J Sex Med , vol.6 , pp. 2133-2142
    • Santoro, N.1    Komi, J.2
  • 4
    • 8644234310 scopus 로고    scopus 로고
    • Self-reported urogenital symptoms in postmenopausal women: Women's Health Initiative
    • DOI 10.1016/j.maturitas.2004.06.019, PII S0378512204002221
    • Pastore LM, Carter RA, Hulka BS, Wells E. Self-reported urogenital symptoms in postmenopausal women: Women's Health Initiative. Maturitas 2004; 49: 292-303 (Pubitemid 39505183)
    • (2004) Maturitas , vol.49 , Issue.4 , pp. 292-303
    • Pastore, L.M.1    Carter, R.A.2    Hulka, B.S.3    Wells, E.4
  • 5
    • 67649365524 scopus 로고    scopus 로고
    • Postmenopausal women's attitudes: Vulvovaginal atrophy and its symptoms
    • [abstract LB-10]
    • Simon JA, Komi J. Postmenopausal women's attitudes: vulvovaginal atrophy and its symptoms [abstract LB-10]. Menopause 2007; 14: 1107
    • (2007) Menopause , vol.14 , pp. 1107
    • Simon, J.A.1    Komi, J.2
  • 6
    • 67649365524 scopus 로고    scopus 로고
    • Impact of menopausal symptoms on sex lives: A survey evaluation
    • [abstract LB-12]
    • Freedman M, Reape KZ, Giblin K. Impact of menopausal symptoms on sex lives: a survey evaluation [abstract LB-12]. Menopause 2007; 14: 1107
    • (2007) Menopause , vol.14 , pp. 1107
    • Freedman, M.1    Reape, K.Z.2    Giblin, K.3
  • 7
    • 51449106068 scopus 로고    scopus 로고
    • Vulvovaginal atrophy is strongly associated with female sexual dysfunction among sexually active postmenopausal women
    • Levine KB, Williams RE, Hartmann KE. Vulvovaginal atrophy is strongly associated with female sexual dysfunction among sexually active postmenopausal women. Menopause 2008; 15: 661-6
    • (2008) Menopause , vol.15 , pp. 661-666
    • Levine, K.B.1    Williams, R.E.2    Hartmann, K.E.3
  • 9
    • 80255138199 scopus 로고    scopus 로고
    • Patterns and predictors of sexual activity among women in the Hormone Therapy trials of the Women's Health Initiative
    • Gass M L, Cochrane BB, Larson J C, et al. Patterns and predictors of sexual activity among women in the Hormone Therapy trials of the Women's Health Initiative. Menopause 2011; 18: 1160-71
    • (2011) Menopause , vol.18 , pp. 1160-1171
    • Gass, M.L.1    Cochrane, B.B.2    Larson, J.C.3
  • 10
    • 61949094584 scopus 로고    scopus 로고
    • Topical estrogen therapy in the management of postmenopausal vaginal atrophy: An up-to-date overview
    • Al-Baghdadi O, Ewies AA. Topical estrogen therapy in the management of postmenopausal vaginal atrophy: an up-to-date overview. Climacteric 2009; 12: 91-105
    • (2009) Climacteric , vol.12 , pp. 91-105
    • Al-Baghdadi, O.1    Ewies, A.A.2
  • 11
    • 0030831296 scopus 로고    scopus 로고
    • A study of European womens' experience of the problems of urogenital ageing and its management
    • DOI 10.1016/S0378-5122(97)00047-9, PII S0378512297000479
    • Barlow D H, Samsioe G, v an Geelen J M. Astudy of European womens ' experience of the problems of urogenital ageing and its management. Maturitas 1997; 27: 239-47 (Pubitemid 27356256)
    • (1997) Maturitas , vol.27 , Issue.3 , pp. 239-247
    • Barlow, D.H.1    Samsioe, G.2    Van Geelen, J.M.3
  • 12
    • 18144421167 scopus 로고    scopus 로고
    • Endometrial cancer and hormone-replacement therapy in the Million Women Study
    • Million Women Study Collaborators
    • Beral V, Bull D, Reeves G, Million Women Study Collaborators. Endometrial cancer and hormone-replacement therapy in the Million Women Study. Lancet 2005; 365: 1543-51
    • (2005) Lancet , vol.365 , pp. 1543-1551
    • Beral, V.1    Bull, D.2    Reeves, G.3
  • 13
    • 0001657785 scopus 로고    scopus 로고
    • Effects of hormone replacement therapy on endometrial histology in postmenopausal women: The Postmenopausal Estrogen/Progestin Interventions (PEPI) Trial
    • The Writing Group for the PEPI Trial
    • Effects of hormone replacement therapy on endometrial histology in postmenopausal women: The Postmenopausal Estrogen/Progestin Interventions (PEPI) Trial. The Writing Group for the PEPI Trial. JAMA 1996; 275: 370-5
    • (1996) JAMA , vol.275 , pp. 370-375
  • 14
    • 84871442791 scopus 로고    scopus 로고
    • Therapeutic options for the treatment of vaginal atrophy
    • Kagan R. Therapeutic options for the treatment of vaginal atrophy. OBG Management 2010; 22: S8-13
    • (2010) OBG Management , vol.22
    • Kagan, R.1
  • 15
    • 77949345161 scopus 로고    scopus 로고
    • Estrogen and progestogen use in postmenopausal women: 2010 position statement of the North American Menopause Society
    • North American Menopause Society
    • North American Menopause Society. Estrogen and progestogen use in postmenopausal women: 2010 position statement of The North American Menopause Society. Menopause 2010; 17: 242-55
    • (2010) Menopause , vol.17 , pp. 242-255
  • 17
    • 84879837382 scopus 로고    scopus 로고
    • Vulvar and vaginal atrophy in postmenopausal women: Findings from the REVIVE (REal Women's VIews of Treatment Options for Menopausal Vaginal ChangEs) survey
    • Kingsberg S A, Wysocki S, Magnus L, Krychman ML. Vulvar and vaginal atrophy in postmenopausal women: Findings from the REVIVE (REal Women's VIews of Treatment Options for Menopausal Vaginal ChangEs) survey. J Sex Med 2013; 10: 1790-9
    • (2013) J Sex Med , vol.10 , pp. 1790-1799
    • Kingsberg, S.A.1    Wysocki, S.2    Magnus, L.3    Krychman, M.L.4
  • 18
    • 68949108335 scopus 로고    scopus 로고
    • Pharmacology and clinical applications of selective estrogen receptor modulators
    • Nath A, Sitruk-Ware R. Pharmacology and clinical applications of selective estrogen receptor modulators. Climacteric 2009; 12: 188-205
    • (2009) Climacteric , vol.12 , pp. 188-205
    • Nath, A.1    Sitruk-Ware, R.2
  • 19
    • 0037434618 scopus 로고    scopus 로고
    • Selective estrogen-receptor modulators - Mechanisms of action and application to clinical practice
    • DOI 10.1056/NEJMra022219
    • Riggs BL, Hartmann LC. Selective estrogen-receptor modulators - mechanisms of action and application to clinical practice. N Engl J Med 2003; 348: 618-29 (Pubitemid 36210865)
    • (2003) New England Journal of Medicine , vol.348 , Issue.7 , pp. 618-629
    • Riggs, B.L.1    Hartmann, L.C.2
  • 20
    • 58649088924 scopus 로고    scopus 로고
    • Cell type- and estrogen receptorsubtype specific regulation of selective estrogen receptor modulator regulatory elements
    • Ball L, Levy N, Zhao X, et al. Cell type- and estrogen receptorsubtype specific regulation of selective estrogen receptor modulator regulatory elements. Mol Cell Endocrinol 2009; 299: 204-11
    • (2009) Mol Cell Endocrinol , vol.299 , pp. 204-211
    • Ball, L.1    Levy, N.2    Zhao, X.3
  • 23
    • 0037145885 scopus 로고    scopus 로고
    • Effects of ospemifene (FC-1271a) on uterine endometrium, vaginal maturation index, and hormonal status in healthy postmenopausal women
    • DOI 10.1016/S0378-5122(02)00206-2, PII S0378512202002062
    • Voipio SK, Komi J, Kangas L, Halonen K, DeGregorio MW, Erkkola RU. Effects of ospemifene (FC- 1271a) on uterine endometrium, vaginal maturation index, and hormonal status in healthy postmenopausal women. Maturitas 2002; 43: 207-14 (Pubitemid 35346550)
    • (2002) Maturitas , vol.43 , Issue.3 , pp. 207-214
    • Voipio, S.K.1    Komi, J.2    Kangas, L.3    Halonen, K.4    DeGregorio, M.W.5    Erkkola, R.U.6
  • 25
    • 0642367765 scopus 로고    scopus 로고
    • Effects of ospemifene, a novel SERM, on hormones, genital tract, climacteric symptoms, and quality of life in postmenopausal women: A double-blind, randomized trial
    • EM, Heikkinen J, Halonen K, Komi J, Lammintausta R, Ylikorkala O. Effects of ospemifene, a novel SERM, on hormones, genital tract, climacteric symptoms, and quality of life in postmenopausal women: a double-blind, randomized trial. Menopause 2003; 10: 433-9
    • (2003) Menopause , vol.10 , pp. 433-439
    • Heikkinen J, E.M.1    Halonen, K.2    Komi, J.3    Lammintausta, R.4    Ylikorkala, O.5
  • 26
    • 77952270259 scopus 로고    scopus 로고
    • Ospemifene effectively treats vulvovaginal atrophy in postmenopausal women: Results from a pivotal phase 3 study
    • Bachmann G A, Komi J O. Ospemifene effectively treats vulvovaginal atrophy in postmenopausal women: results from a pivotal phase 3 study. Menopause 2010; 17: 480-6
    • (2010) Menopause , vol.17 , pp. 480-486
    • Bachmann, G.A.1    Komi, J.O.2
  • 27
    • 85028098042 scopus 로고    scopus 로고
    • One-year longterm safety extension study of ospemifene for the treatment of vulvar and vaginal atrophy in postmenopausal women with a uterus
    • Simon J A, Lin V H, Radovich C, Bachmann G A. One-year longterm safety extension study of ospemifene for the treatment of vulvar and vaginal atrophy in postmenopausal women with a uterus. Menopause 2012; 20: 418-27
    • (2012) Menopause , vol.20 , pp. 418-427
    • Simon, J.A.1    Lin, V.H.2    Radovich, C.3    Bachmann, G.A.4
  • 28
    • 84879172530 scopus 로고    scopus 로고
    • Ospemifene, a novel selective estrogen receptor modulator for treating dyspareunia associated with postmenopausal vulvar and vaginal atrophy
    • Portman D J, Bachmann G A, Simon J A. Ospemifene, a novel selective estrogen receptor modulator for treating dyspareunia associated with postmenopausal vulvar and vaginal atrophy. Menopause 2013; 20: 623-30
    • (2013) Menopause , vol.20 , pp. 623-630
    • Portman, D.J.1    Bachmann, G.A.2    Simon, J.A.3
  • 29
    • 4344626547 scopus 로고    scopus 로고
    • Anatomy and histology of the uterine corpus
    • Kurman RJ, ed., 5th edn. New York: Springer-Verlag
    • Mutter G L, Ferenczy A. Anatomy and histology of the uterine corpus. In Kurman RJ, ed. Blaustein's Pathology of the Female Genital Tract, 5th edn. New York: Springer-Verlag, 2002: 383-420
    • (2002) Blaustein's Pathology of the Female Genital Tract , pp. 383-420
    • Mutter, G.L.1    Ferenczy, A.2
  • 30
    • 0345257213 scopus 로고    scopus 로고
    • Estrogenic effects of toremifene and tamoxifen in postmenopausal breast cancer patients
    • DOI 10.1023/B:BREA.0000003957.54851.11
    • Ellm é n J, Hakulinen P, Partanen A, Hayes DF. Estrogenic effects of toremifene and tamoxifen in postmenopausal breast cancer patients. Breast Cancer Res Treat 2003; 82: 103-11 (Pubitemid 37476010)
    • (2003) Breast Cancer Research and Treatment , vol.82 , Issue.2 , pp. 103-111
    • Ellmen, J.1    Hakulinen, P.2    Partanen, A.3    Hayes, D.F.4
  • 31
    • 0035680470 scopus 로고    scopus 로고
    • The effect of selective estrogen receptor modulators on parameters of the hypothalamic-pituitary-gonadal axis
    • Plouffe L Jr, Siddhanti S. The effect of selective estrogen receptor modulators on parameters of the hypothalamic-pituitary-gonadal axis. Ann N Y Acad Sci 2001; 949: 251-8 (Pubitemid 34059987)
    • (2001) Annals of the New York Academy of Sciences , vol.949 , pp. 251-258
    • Plouffe Jr., L.1    Siddhanti, S.2
  • 32
    • 77952228433 scopus 로고    scopus 로고
    • Endometrial safety: A key hurdle for selective estrogen receptor modulators in development
    • Pinkerton JV, Goldstein SR. Endometrial safety: a key hurdle for selective estrogen receptor modulators in development. Menopause 2010; 17: 642-53
    • (2010) Menopause , vol.17 , pp. 642-653
    • Pinkerton, J.V.1    Goldstein, S.R.2
  • 33
    • 67649574704 scopus 로고    scopus 로고
    • Designing the ideal selective estrogen receptor modulator - an achievable goal?
    • Taylor HS. Designing the ideal selective estrogen receptor modulator - an achievable goal? Menopause 2009; 16: 609-15
    • (2009) Menopause , vol.16 , pp. 609-615
    • Taylor, H.S.1
  • 36
    • 33745259890 scopus 로고    scopus 로고
    • Not all SERMs are created equal
    • Goldstein SR. Not all SERMs are created equal. Menopause 2006; 13: 325-7
    • (2006) Menopause , vol.13 , pp. 325-327
    • Goldstein, S.R.1
  • 38
    • 0033625643 scopus 로고    scopus 로고
    • 17β-estradiol vaginal tablet versus conjugated equine estrogen vaginal cream to relieve menopausal atrophic vaginitis
    • Rioux JE, Devlin C, Gelfand MM, Steinberg WM, Hepburn DS. 17beta-estradiol vaginal tablet versus conjugated equine estrogen vaginal cream to relieve menopausal atrophic vaginitis. Menopause 2000; 7: 156-61 (Pubitemid 30249896)
    • (2000) Menopause , vol.7 , Issue.3 , pp. 156-161
    • Rioux, J.E.1    Devlin, M.C.2    Gelfand, M.M.3    Steinberg, W.M.4    Hepburn, D.S.5
  • 40
    • 84896339791 scopus 로고    scopus 로고
    • [package insert]. Princeton NJ Novo Nordisk Inc.;
    • Vagifem [package insert]. Princeton, NJ: Novo Nordisk Inc.; 2012
    • (2012) Vagifem
  • 41
    • 58149510509 scopus 로고    scopus 로고
    • Prevalence of endometrial polyps and abnormal uterine bleeding in a Danish population aged 20-74 years
    • Dreisler E, Sorensen S S, Ibsen P H, Lose G. Prevalence of endometrial polyps and abnormal uterine bleeding in a Danish population aged 20-74 years. Ultrasound Obstet Gynecol 2009; 33: 102-8
    • (2009) Ultrasound Obstet Gynecol , vol.33 , pp. 102-108
    • Dreisler, E.1    Sorensen, S.S.2    Ibsen, P.H.3    Lose, G.4
  • 42
    • 84655163386 scopus 로고    scopus 로고
    • Ospemifene and 4-hydroxyospemifene effectively prevent and treat breast cancer in the MTag
    • Burich R A, Mehta N R, Wurz G T, et al. Ospemifene and 4-hydroxyospemifene effectively prevent and treat breast cancer in the MTag. Tg transgenic mouse model. Menopause 2012; 19: 96-103
    • (2012) Tg Transgenic Mouse Model. Menopause , vol.19 , pp. 96-103
    • Burich, R.A.1    Mehta, N.R.2    Wurz, G.T.3
  • 43
    • 84875434415 scopus 로고    scopus 로고
    • Ospemifene, vulvovaginal atrophy, and breast cancer
    • Jan 15. Epub ahead of print
    • Wurz GT, Soe LH, DeGregorio MW. Ospemifene, vulvovaginal atrophy, and breast cancer. Maturitas 2013 Jan 15. Epub ahead of print
    • (2013) Maturitas
    • Wurz, G.T.1    Soe, L.H.2    Degregorio, M.W.3
  • 44
    • 0034907007 scopus 로고    scopus 로고
    • In vitro and in vivo biologic effects of Ospemifene (FC-1271a) in breast cancer
    • DOI 10.1016/S0960-0760(01)00066-8, PII S0960076001000668
    • Taras TL, Wurz GT, DeGregorio MW. In vitro and in vivo biologic effects of ospemifene (FC-1271a) in breast cancer. J Steroid Biochem Mol Biol 2001; 77: 271-9 (Pubitemid 32703625)
    • (2001) Journal of Steroid Biochemistry and Molecular Biology , vol.77 , Issue.4-5 , pp. 271-279
    • Taras, T.L.1    Wurz, G.T.2    DeGregorio, M.W.3
  • 45
    • 46649093380 scopus 로고    scopus 로고
    • The effect of tamoxifen on the genital tract
    • DOI 10.1102/1470-7330.2008.0020
    • Polin SA, Ascher SM. The effect of tamoxifen on the genital tract. Cancer Imaging 2008; 8: 135-45 (Pubitemid 351936271)
    • (2008) Cancer Imaging , vol.8 , Issue.1 , pp. 135-145
    • Polin, S.A.1    Ascher, S.M.2
  • 46
    • 33745253921 scopus 로고    scopus 로고
    • Prevention of bone loss in postmenopausal women treated with lasofoxifene compared with raloxifene
    • McClung M R, Siris E, Cummings S, et al. Prevention of bone loss in postmenopausal women treated with lasofoxifene compared with raloxifene. Menopause 2006; 13: 377-86
    • (2006) Menopause , vol.13 , pp. 377-386
    • McClung, M.R.1    Siris, E.2    Cummings, S.3
  • 48
    • 0034639224 scopus 로고    scopus 로고
    • Long-term effects of raloxifene on bone mineral density, bone turnover, and serum lipid levels in early postmenopausal women: Three-year data from 2 double-blind, randomized, placebo-controlled trials
    • Johnston CC Jr, Bjarnason NH, Cohen FJ, et al. Long-term effects of raloxifene on bone mineral density, bone turnover, and serum lipid levels in early postmenopausal women: three-year data from 2 double-blind, randomized, placebo-controlled trials. Arch Intern Med 2000; 160: 3444-50
    • (2000) Arch Intern Med , vol.160 , pp. 3444-3450
    • Johnston Jr., C.C.1    Bjarnason, N.H.2    Cohen, F.J.3


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