To evaluate the efficacy and safety of different doses of 17β-estradiol for the treatment of vasomotor and vulvovaginal symptoms.
This was a randomized, double-blind, multicenter, parallel-group study. One hundred forty-five subjects, including naturally postmenopausal women aged 40-60 (who had not experienced menses for at least 12 months), women who had undergone hysterectomy, and women aged 25-60 who had undergone bilateral oophorectomy with or without hysterectomy were studied. Either placebo or 17β-estradiol (1 mg or 0.5 mg) was given orally every day for 12 weeks, and vasomotor symptoms and vaginal epithelial cytology were evaluated.
There were significant differences between placebo and the active treatments in the percentage change from baseline in the number of hot flushes (all hot flushes, 1 mg vs. placebo, p < 0.001; 0.5 mg vs. placebo, p = 0.007), with a more substantial proportion of subjects responding in the 1-mg group (mean change in mean number of hot flushes of 83.2%). Both doses were also more effective than placebo in increasing the proportion of mature vaginal cells (end-of-treatment mean values of 0%, 78.5%, and 21.5% for parabasal, intermediate, and superficial cells, respectively, in the 1-mg group; mean values of 0.3%, 80.8%, and 18.9% in the 0.5-mg group; and mean values of 15.2%, 74.7%, and 10.2% in the placebo group). The proportion of subjects reporting no vaginal dryness was greatest in the 1-mg group (mean percentage of days without dryness of 86.1% at weeks 9-12).
For the relief of vasomotor and vulvovaginal symptoms, 17β-estradiol 1 mg is effective and has an excellent safety profile. (Menopause 2000;7:310-317. © 2000, The North American Menopause Society.)
Received August 27, 1999; revised and accepted March 10, 2000.
Dr. Notelovitz is the President and Founder Emeritus of the Women's Medical & Diagnostic Center.
Address reprint requests to Morris Notelovitz, MD, PhD, 2801 NW 58 Blvd., Gainesville, FL 32605.
©2000The North American Menopause Society