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Efficacy of a new, oral estradiol acetate formulation for relief of menopause symptoms

Speroff, Leon MD1; Haney, Arthur F. MD2; Gilbert, Richard D. PhD3; Ellman, Herman MD4for the Estradiol Acetate Investigator Group

doi: 10.1097/01.gme.0000182802.06762.b2
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Objective: To determine the efficacy of three doses of a new, oral formulation of estradiol acetate (EA) for alleviation of vasomotor and urogenital symptoms in postmenopausal women.

Design: Two separate 12-week studies were undertaken in postmenopausal women with moderate to severe vasomotor symptoms. In the first study, women were randomly assigned to EA 0.9 mg/day, EA 1.8 mg/day, or placebo (study 1; N = 293), and in the second study to oral EA 0.45 mg/day or placebo (study 2; N = 259). Women recorded the frequency and severity of vasomotor symptoms daily and urogenital symptoms weekly on diary cards. Investigators assessed signs of vaginal atrophy.

Results: Frequency of moderate to severe vasomotor symptoms decreased significantly versus placebo, starting at week 2 in the EA 1.8-mg group (P = 0.005), week 3 in the EA 0.9-mg group (P = 0.003), and week 6 in the EA 0.45-mg group (P < 0.05). At week 12, mean percent reduction from baseline in vasomotor-symptom frequency was 91%, 78%, and 61%, respectively. Vasomotor-symptom severity decreased significantly versus placebo, starting at weeks 2 and 3 with EA 1.8 mg and 0.9 mg, respectively, and at week 5 with EA 0.45 mg. Vaginal pH and maturation index improved significantly in all EA groups versus placebo, and some signs and symptoms of vaginal atrophy improved at the EA 0.9- and 1.8-mg doses. Side effects were mild to moderate and consistent with estrogen therapy.

Conclusions: Oral EA at all doses was well tolerated and significantly reduced the frequency and severity of postmenopause symptoms versus placebo.

Three doses of estradiol acetate, including a 0.45-mg dose that is equivalent to 0.38 mg estradiol, have been demonstrated to be effective for the treatment of postmenopausal hot flushing.

From the 1Department of Obstetrics and Gynecology, Oregon Health & Science University, Portland, OR; 2Department of Obstetrics and Gynecology, University of Chicago, Chicago, IL; 3TKL Research, Inc., Rochelle Park, NJ; and 4Warner Chilcott (US), Inc., Rockaway, NJ.

Received May 24, 2005; revised and accepted August 4, 2005.

This study was supported by Warner Chilcott (US), Inc., which developed this product.

Address correspondence to: Herman Ellman, MD, Warner Chilcott (US), Inc., Rockaway 80 Corporate Center, 100 Enterprise Drive, Suite 280, Rockaway, NJ 07866. E-mail: hellman@wcrx.com.

©2006The North American Menopause Society