Endometrial safety of ultra-low-dose estradiol vaginal tablets

Obstetrics and Gynecology

Volumn 116, Issue 4, 2010, Pages 876-883

  Simon, James ^a   Nachtigall, Lila ^b   Ulrich, Lian G ^b   Eugster Hausmann, Michaela ^b   Gut, Robert ^b  

^a Women's Health and Research Consultants   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

ESTRADIOL; PLACEBO; AGENTS USED INTRAVAGINALLY; ESTROGEN;

ADULT; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EXPOSURE; DRUG SAFETY; ENDOMETRIOID ADENOCARCINOMA; ENDOMETRIOID CARCINOMA; ENDOMETRIUM; ENDOMETRIUM BIOPSY; ENDOMETRIUM CARCINOMA; ENDOMETRIUM HYPERPLASIA; ENDOMETRIUM POLYP; ESTROGEN THERAPY; FEMALE; HISTOPATHOLOGY; HUMAN; INCIDENCE; LABORATORY; LOW DRUG DOSE; MAJOR CLINICAL STUDY; OPEN STUDY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RISK FACTOR; TABLET; TREATMENT DURATION; VAGINA ATROPHY; ATROPHY; CHEMICALLY INDUCED; ENDOMETRIAL HYPERPLASIA; ENDOMETRIAL NEOPLASMS; MIDDLE AGED; MULTICENTER STUDY; PATHOLOGY; PATIENT SELECTION; VAGINA;

ATROPHY; DOUBLE-BLIND METHOD; ENDOMETRIAL HYPERPLASIA; ENDOMETRIAL NEOPLASMS; ESTRADIOL; ESTROGENS; FEMALE; HUMANS; MIDDLE AGED; PATIENT SELECTION; VAGINA; VAGINAL CREAMS, FOAMS, AND JELLIES;

EID: 77957237747     PISSN: 00297844     EISSN: None     Source Type: Journal    
DOI: 10.1097/AOG.0b013e3181f386bb     Document Type: Article

References (21)

1. Archer DF. Efficacy and tolerability of local estrogen therapy for urogenital atrophy. Menopause 2010;17:194-203.
2. Bachmann GA, Nevadunsky NS. Diagnosis and treatment of atrophic vaginitis. Am Fam Physician 2000;61:3090-3096
3. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research. Guidance for industry: estrogen and estrogen/pro-gestin drug products to treat vasomotor symptoms and vulvar and vaginal atrophy symptoms\recommendations for clinical evaluation. Washington, DC: U.S. Department of Health and Human Services; 2003.
4. Archer DF. Efficacy and tolerability of local estrogen therapy for urogenital atrophy. Menopause Epub ahead of print 2010 July 13.
5. Beard MK. Atrophic vaginitis. Can it be prevented as well as treated? Postgrad Med 1992;91:257-260
6. Pandit L, Ouslander JG. Postmenopausal vaginal atrophy and atrophic vaginitis. Am J Med Sci 1997;314:228-231
7. 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(3 Pt 1):355-369
8. 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
9. Ulrich LS, Naessen T, Elia D, Goldstein JA, Eugster-Haus-mann M, VAG-1748 Trial Investigators. Endometrial safety of ultra-low-dose Vagifem 10 microg in postmenopausal women with vaginal atrophy. Climacteric 2010;13:228-237
10. Committee for Medical Products for Human Use (CHMP). Guideline on clinical investigation of medical products for hormone replacement therapy of oestrogen deficiency symptoms in postmenopausal women. London (UK): European Medicines Agency; 2005.
11. American Cancer Society. Cancer facts and figures 2009. Atlanta (GA): American Cancer Society; 2009.
12. Furness S, Roberts H, Marjoribanks J, Lethaby A, Hickey M, Farquhar C. Hormone therapy in postmenopausal women and risk of endometrial hyperplasia. The Cochrane Database of Systematic Reviews 2009, Issue 2. Art. No.: CD000402. DOI: 10.1002/14651858.CD000402.pub3.
13. Utian WH, Bachmann GA, Cahill EB, Gallagher JC, Grodstein F, Heiman JR, et al. Estrogen and progestogen use in post-menopausal women: 2010 position statement of The North American Menopause Society. Menopause 2010;17:242-255
14. Rossouw JE, Anderson GL, Prentice RL, LaCroix AZ, Kooper-berg C, Stefanick ML, et al. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women's Health Initiative randomized controlled trial. JAMA 2002;288:321-333
15. Cobin RH, Futterweit W, Ginzburg SB, Goodman NF, Kleerekoper M, Licata AA, et al. American Association of Clinical Endocrinologists medical guidelines for clinical practice for the diagnosis and treatment of menopause. Endocrinol Pract 2006;12:315-337
16. Gompel A, Rozenberg S, Barlow DH, EMAS Board Members. The EMAS 2008 update on clinical recommendations on postmenopausal hormone replacement therapy. Maturitas 2008;61:227-232
17. Board of International Menopause Society, Pines A, Sturdee DW, Birkhauser MH, Schneider HP, Gambacciani M, Panay N. IMS updated recommendations on postmenopausal hormone therapy. Climacteric 2007;10:181-194 (Pubitemid 46752441)
18. Bachmann G, Lobo RA, Gut R, Nachtigall L, Notelovitz M. Efficacy of low-dose estradiol vaginal tablets in the treatment of atrophic vaginitis: a randomized controlled trial. Obstet Gynecol 2008;111:67-76.
19. Green PK, Weiss NS, McKnight B, Voigt LF, Beresford SA. Risk of endometrial cancer following cessation of menopausal hormone use (Washington, United States). Cancer Causes Control 1996;7:575-580
20. Sturdee DW. Endometrial cancer and HRT. Rev Gynaecol Pract 2005;5:51-56
21. Reed SD, Newton KM, Clinton WL, Epplein M, Garcia R, Allison K, et al. Incidence of endometrial hyperplasia. Am J Obstet Gynecol 2009;200:678-686