2005P-0037
CP 1
Volume 1

Citizen Petition

Attachment 1 - http://www.accessdata.fda.gov/scripts/cder/ob/docs/tempai.cfm

Attachment 2 - O’Connell, Mary Beth. Pharmacokinetic and Pharmacologic Variation Between Different Estrogen Products, J Clin Pharmacol 1995; 35: 18S-24S.

Attachment 3 - Nilsson, K and G. Heimer. Low-dose oestradiol in the treatment of urogenital oestrogen deficiency - a pharmacokinetic and pharmacodynamic study, Maturitas 1992 Oct; 15 (2):121-127.

Attachment 4 - Crandall, Carolyn, M.D. Vaginal Estrogen Preparations: A Review of Safety and Efficacy for Vaginal Atrophy, Journal of Women's Health 2002; 11: 857-877.

Attachment 5 - Pharmacia, Estring estradiol vaginal ring, Physician's Leaflet.

Attachment 6 - Barentsen, Ronald, Peter H. M. van de Weijer, Jan M. N. Schram. Continuous low dose estradiol released from a vaginal ring versus estriol vaginal cream for urogenital atrophy, Eur J Obstet Gynecol Reprod Biol 1997 Jan; 71 (1): 73-80.

Attachment 7 - Suckling J., A. Lethaby, and R. Kennedy. Local oestrogen for vaginal atrophy in postmenopausal women. John Wiley & Sons Ltd 2004.

Attachment 8 - Henriksson, Lars et al. A comparative multicenter study of the effects of continuous low-dose estradiol released from a new vaginal ring versus estriol vaginal pessaries in postmenopausal women with symptoms and signs of urogenital atrophy, Amer J Obstet Gynecol 1994 Sep; 171 (5): 624-632.

Attachment 9 - Dugal, Randi et al. Comparison of usefulness of estradiol vaginal tablets and estriol vagitories for treatment of vaginal atrophy, Acta Obstet Gynecol Scand 2000; 79: 293-297.

Attachment 10 - Rioux, Jacques Emile et al. 17B-Estradiol Vaginal Tablet Versus Conjugated Equine Estrogen Vaginal Cream to Relieve Menopausal Atrophic Vaginitis, Menopause 7: 156-161.