Suppression of vasomotor and vulvovaginal symptoms with continuous oral 17beta-estradiol.
OBJECTIVE
To evaluate the efficacy and safety of different doses of 173-estradiol for the treatment of vasomotor and vulvovaginal symptoms.


METHODS
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 17beta-estradiol (1 mg or 0.5 mg) was given orally every day for 12 weeks, and vasomotor symptoms and vaginal epithelial cytology were evaluated.


RESULTS
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 < 0.00 1; 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).


CONCLUSIONS
For the relief of vasomotor and vulvovaginal symptoms, 17beta-estradiol I mg is effective and has an excellent safety profile.
Notelovitz
M
M
Women's Medical & Diagnostic Center, Gainesville, Florida, USA.
Mattox
J H
JH
D000284:Administration, Oral; D000328:Adult; D001284:Atrophy / Q000517:prevention & control; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004958:Estradiol / Q000008:administration & dosage / Q000627:therapeutic use*; D015914:Estrogen Replacement Therapy; D005260:Female; D019584:Hot Flashes / Q000517:prevention & control*; D006801:Humans; D008875:Middle Aged; D017698:Postmenopause; D014481:United States; D014621:Vagina / Q000187:drug effects / Q000473:pathology; D014623:Vaginal Diseases / Q000473:pathology / Q000517:prevention & control*; D014845:Vulvar Diseases / Q000473:pathology / Q000517:prevention & control*
D004958:Estradiol