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.
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.
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.
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: firstname.lastname@example.org.