1,188
Views
37
CrossRef citations to date
0
Altmetric
ORIGINAL ARTICLES

The clinical relevance of the effect of ospemifene on symptoms of vulvar and vaginal atrophy

, , , , &
Pages 233-240 | Received 11 Aug 2014, Accepted 06 Oct 2014, Published online: 16 Dec 2014

References

  • Parish SJ, Nappi RE, Krychman ML, et al. Impact of vulvovaginal health on postmenopausal women: a review of surveys on symptoms of vulvovaginal atrophy. Int J Womens Health 2013; 5:437–47
  • Mac Bride MB, Rhodes DJ, Shuster LT. Vulvovaginal atrophy. Mayo Clin Proc 2010;85:87–94
  • Castelo-Branco C, Cancelo MJ, Villero J, Nohales F, Juliá MD. Management of post-menopausal vaginal atrophy and atrophic vaginitis. Maturitas 2005;52(Suppl 1):S46–52
  • Bachmann GA, Nevadunsky NS. Diagnosis and treatment of atrophic vaginitis. Am Fam Physician 2000;61:3090–6
  • Goldstein I, Alexander JL. Practical aspects in the management of vaginal atrophy and sexual dysfunction in perimenopausal and postmenopausal women. J Sex Med 2005;2(Suppl 3):154–65
  • Goldstein I. Recognizing and treating urogenital atrophy in postmenopausal women. J Womens Health (Larchmt) 2010;19: 425–32
  • Goldstein I, Dicks B, Kim NN, Hartzell R. Multidisciplinary overview of vaginal atrophy and associated genitourinary symptoms in postmenopausal women. Sex Med 2013;1:44–53
  • Sturdee DW, Panay N. Recommendations for the management of postmenopausal vaginal atrophy. Climacteric 2010;13:509–22
  • Robinson D, Cardozo L. The menopause and HRT. Urogenital effects of hormone therapy. Best Pract Res Clin Endocrinol Metab 2003;17:91–104
  • Management of symptomatic vulvovaginal atrophy: 2013 position statement of The North American Menopause Society. Menopause 2013;20:888–902
  • Nappi RE, Palacios S. Impact of vulvovaginal atrophy on sexual health and quality of life at postmenopause. Climacteric 2014;17:3–9
  • Nappi RE, Lachowsky M. Menopause and sexuality: prevalence of symptoms and impact on quality of life. Maturitas 2009;63: 138–41
  • Palacios S. Managing urogenital atrophy. Maturitas 2009;63: 315–18
  • Bachmann GA, Leiblum SR. Sexuality in sexagenarian women. Maturitas 1991;13:43–50
  • 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
  • Rees M, Pérez-López FR, Ceasu I, et al. EMAS clinical guide: low-dose vaginal estrogens for postmenopausal vaginal atrophy. Maturitas 2012;73:171–4
  • Kingsberg SA, 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
  • Panay N, Fenton A. Vulvovaginal atrophy – a tale of neglect. Climacteric 2014;17:1–2
  • Guidance for Industry: Estrogen and Estrogen/Progestin Drug Products to Treat Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms – Recommendations for Clinical Evaluation. Draft guidance, Food and Drug Administration. January 2003. At http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm071643.pdf, accessed 4 July 2014
  • Ettinger B, Hait H, Reape KZ, Shu H. Measuring symptom relief in studies of vaginal and vulvar atrophy: the most bothersome symptom approach. Menopause 2008;15:885–9
  • Ospemifene prescribing information. Shionogi, 2013
  • Bachmann GA, Komi JO. Ospemifene effectively treats vulvovaginal atrophy in postmenopausal women: results from a pivotal phase 3 study. Menopause 2010;17:480–6
  • 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;20:623–30
  • Portman D, Palacios S, Nappi RE, Mueck AO. Ospemifene, a non-oestrogen selective oestrogen receptor regulator for the treatment of vaginal dryness associated with postmenopausal vulvar and vaginal atrophy: a randomised, placebo-controlled, phase III trial. Maturitas 2014;78:91–8
  • Goldstein SR, Bachmann GA, Koninckx PR, Lin VH, Portman DJ, Ylikorkala O. Ospemifene 12-month safety and efficacy in postmenopausal women with vulvar and vaginal atrophy. Climacteric 2014;17:173–82
  • Simon JA, Lin VH, Radovich C, Bachmann GA. One-year long-term safety extension study of ospemifene for the treatment of vulvar and vaginal atrophy in postmenopausal women. Menopause 2012;20:418–27
  • Simon JA, Portman D, Mabey RG Jr; Ospemifene Study Group Long-term safety of ospemifene (52-week extension) in the treatment of vulvar and vaginal atrophy in hysterectomized postmenopausal women. Maturitas 2014;77:274–81
  • Simon JA, Reape KZ, Wininger S, Hait H. Randomized, multicenter, double-blind, placebo-controlled trial to evaluate the efficacy and safety of synthetic conjugated estrogens B for the treatment of vulvovaginal atrophy in healthy postmenopausal women. Fertil Steril 2008;90:1132–8
  • Bachmann G, Bouchard C, Hoppe D, et al. Efficacy and safety of low-dose regimens of conjugated estrogens cream administered vaginally. Menopause 2009;16:719–27
  • Freedman M, Kaunitz AM, Reape KZ, Hait H, Shu H. Twice-weekly synthetic conjugated estrogens vaginal cream for the treatment of vaginal atrophy. Menopause 2009;16: 735–41
  • Simon J, Nachtigall L, Gut R, Lang E, Archer DF, Utian W. Effective treatment of vaginal atrophy with an ultra-low-dose estradiol vaginal tablet. Obstet Gynecol 2008;112:1053–60
  • Griesser H, Skonietzki S, Fischer T, Fielder K, Suesskind M. Low dose estriol pessaries for the treatment of vaginal atrophy: a double-blind placebo-controlled trial investigating the efficacy of pessaries containing 0.2 mg and 0.03 mg estriol. Maturitas 2012;71:360–8
  • Kagan R, Williams RS, Pan K, Mirkin S, Pickar JH. A randomized, placebo- and active-controlled trial of bazedoxifene/conjugated estrogens for treatment of moderate to severe vulvar/vaginal atrophy in postmenopausal women. Menopause 2010; 17:281–9
  • Labrie F, Archer DF, Bouchard C, et al. Intravaginal dehydroepiandrosterone (prasterone), a highly efficient treatment of dyspareunia. Climacteric 2011;14:282–8
  • Bradford A. Listening to placebo in clinical trials for female sexual dysfunction. J Sex Med 2013;10:451–9
  • Constantine G, Graham S, Koltun WD, Kingsberg SA. Assessment of ospemifene or lubricants on clinical signs of VVA. J Sex Med 2014;11:1033–41