Endometrial safety of ultra-low-dose Vagifem 10 μg in postmenopausal women with vaginal atrophy

References

• Nelson HD. Menopause. Lancet 2008;371:760–770
   PubMed Web of Science ®Google Scholar
• Anderson GL, Judd HL, Kaunitz AM, et al Effects of estrogen plus progestin on gynecologic cancers and associated diagnostic procedures: the Women's Health Initiative randomized trial. JAMA 2003;290:1739–1748
   PubMed Web of Science ®Google Scholar
• Beral V, Bull D, Reeves G. Endometrial cancer and hormone-replacement therapy in the Million Women Study. Lancet 2005;365:1543–1551
   PubMed Web of Science ®Google Scholar
• 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. JAMA 1996;275:370–375
   PubMed Web of Science ®Google Scholar
• The 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;14:355–369
   PubMed Web of Science ®Google Scholar
• Cardozo L, Bachmann G, McClish D, Fonda D, Birgerson L. Meta-analysis of estrogen therapy in the management of urogenital atrophy in postmenopausal women: second report of the Hormones and Urogenital Therapy Committee. Obstet Gynecol 1998;92:722–727
   PubMed Web of Science ®Google Scholar
• Suckling J, Lethaby A, Kennedy R. Local oestrogen for vaginal atrophy in 22 postmenopausal women. Cochrane Database Syst Rev 2006;(4): CD001500
   PubMed Web of Science ®Google Scholar
• US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Guidance For Industry, Labeling Guidance for Noncontraceptive Estrogen Drug Products for the Treatment of Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms – Prescribing Information for Health Care Providers and Patient Labeling. November 2005, Revision 4
   Google Scholar
• Pines A, Sturdee DW, Birkhäuser MH, Schneider HP, Gambacciani M, Panay N. IMS updated recommendations on postmenopausal hormone therapy. Climacteric 2007;10:181–194
   PubMed Web of Science ®Google Scholar
• Utian WH, Archer DF, Bachmann GA, et al Estrogen and progestogen use in postmenopausal women: July 2008 position statement of The North American Menopause Society. Menopause 2008;15:584–602
   PubMed Web of Science ®Google Scholar
• Skouby SO, Al-Azzawi F, Barlow D, et al Climacteric medicine: European Menopause and Andropause Society (EMAS) 2004/2005 position statements on peri- and postmenopausal hormone replacement therapy. Maturitas 2005;51:8–14
   PubMed Web of Science ®Google Scholar
• 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;112:1053–1060
   PubMed Web of Science ®Google Scholar
• Elsandabesee D, Greenwood P. The performance of Pipelle endometrial sampling in a dedicated postmenopausal bleeding clinic. J Obstet Gynaecol 2005;25:32–34
   PubMedGoogle Scholar
• Youssif SN, McMillan DL. Outpatient endometrial biopsy: the pipelle. Br J Hosp Med 1995;54:198–201
   PubMed Web of Science ®Google Scholar
• Hanley JA, Lippman-Hand A. If nothing goes wrong, is everything all right? Interpreting zero numerators. JAMA 1983;249:1743–1745
   PubMed Web of Science ®Google Scholar
• Weiderpass E, Baron JA, Adami HO, et al Low-potency oestrogen and risk of endometrial cancer: a case-control study. Lancet 1999;353:1824–1828
   PubMed Web of Science ®Google Scholar
• Bachmann G, Bouchard C, Hoppe D, et al Efficacy and safety of low-dose regimens of conjugated estrogens cream administered vaginally. Menopause 2009;16:719–727
   PubMed Web of Science ®Google Scholar
• Mettler L, Olsen PG. Long-term treatment of atrophic vaginitis with low-dose oestradiol vaginal tablets. Maturitas 1991;14:23–31
   PubMed Web of Science ®Google Scholar
• Viola AS, Gouveia D, Andrade L, Aldrighi JM, Viola CF, Bahamondes L. Prevalence of endometrial cancer and hyperplasia in non-symptomatic overweight and obese women. Aust N Z J Obstet Gynaecol 2008;48:207–213
   PubMed Web of Science ®Google Scholar
• Smith-Bindman R, Weiss E, Feldstein V. How thick is too thick? When endometrial thickness should prompt biopsy in postmenopausal women without vaginal bleeding. Ultrasound Obstet Gynecol 2004;24:558–565
   PubMed Web of Science ®Google Scholar
• Mainini G, Scaffa C, Rotondi M, Messalli EM, Quirino L, Ragucci A. Local estrogen replacement therapy in postmenopausal atrophic vaginitis: efficacy and safety of low dose 17beta-estradiol vaginal tablets. Clin Exp Obstet Gynecol 2005;32:111–113
   PubMedGoogle Scholar
• Salminen HS, Saaf ME, Johansson SE, Ringertz H, Strender LE. The effect of transvaginal estradiol on bone in aged women: a randomised controlled trial. Maturitas 2007;57:370–381
   PubMed Web of Science ®Google Scholar
• Trevoux R, De BJ, Castanier M, Nahoul K, Soule JP, Scholler R. Endometrium and plasma hormone profile in the peri-menopause and post-menopause. Maturitas 1986;8:309–326
   PubMed Web of Science ®Google Scholar
• Kurman RJ, Kaminski PF, Norris HJ. The behavior of endometrial hyperplasia. A long-term study of “untreated” hyperplasia in 170 patients. Cancer 1985;56:403–412
   PubMed Web of Science ®Google Scholar
• Pickar JH, Yeh IT, Wheeler JE, Cunnane MF, Speroff L. Endometrial effects of lower doses of conjugated equine estrogens and medroxyprogesterone acetate: two-year substudy results. Fertil Steril 2003;80:1234–1240
   PubMed Web of Science ®Google Scholar
• 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;7:156–161
   PubMed Web of Science ®Google Scholar
• Weisberg E, Ayton R, Darling G, et al Endometrial and vaginal effects of low-dose estradiol delivered by vaginal ring or vaginal tablet. Climacteric 2005;8:83–92
   PubMed Web of Science ®Google Scholar
• Bachmann G, Bouchard C, Hoppe D, et al Efficacy and safety of low-dose regimens of conjugated estrogens cream administered vaginally. Menopause 2009;16:719–727
   PubMed Web of Science ®Google Scholar
• Dreisler E, Stampe SS, Ibsen PH, Lose G. Prevalence of endometrial polyps and abnormal uterine bleeding in a Danish population aged 20–74 years. Ultrasound Obstet Gynecol 2009;33:102–108
   PubMed Web of Science ®Google Scholar
• Tourgeman DE, Slater CC, Stanczyk FZ, Paulson RJ. Endocrine and clinical effects of micronized estradiol administered vaginally or orally. Fertil Steril 2001;75:200–202
   PubMed Web of Science ®Google Scholar
• US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Guidance for Industry, Estrogen and Estrogen/Progestin Drug Products to Treat Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms – Recommendation for Clinical Evaluation. January 2003
   Google Scholar
• Haspels AA, Luisi M, Kicovic PM. Endocrinological and clinical investigations in post-menopausal women following administration of vaginal cream containing oestriol. Maturitas 1981;3:321–327
   PubMed Web of Science ®Google Scholar
• Kvorning I, Daugbjerg NU, Jensen HK, Saurbrey N, Fink B. Pharmaceutical development of low-dose estradiol vagitories in The Urogenital Oestrogen Deficiency Syndrome. Proceedings of International Workshop, Copenhagen, November 7th 1986 (editors Goran Samsioe and Peter Bonne Eriksen). ISBN 87-87161-03-6. Copyright NOVO Industry A/S 1987. The workshop was organized by NOVO Industry
   Google Scholar
• Nilsson K, Heimer G. Low-dose oestradiol in the treatment of urogenital oestrogen deficiency – a pharmacokinetic and pharmacodynamic study. Maturitas 1992;15:121–127
   PubMed Web of Science ®Google Scholar
• Burger H. The menopausal transition – endocrinology. J Sex Med 2008;5:2266–2273
   PubMed Web of Science ®Google Scholar
• Foidart JM, Vervliet J, Buytaert P. Efficacy of sustained-release vaginal oestriol in alleviating urogenital and systemic climacteric complaints. Maturitas 1991;13:99–107
   PubMed Web of Science ®Google Scholar
• Nachtigall LE. Clinical trial of the estradiol vaginal ring in the US. Maturitas 1995;22(Suppl):S43–S47
   PubMedGoogle Scholar