Abstract
Objective: To assess the efficacy and safety of 17-β estradiol buccal tablets in reducing hot
flush frequency (HFF) in postmenopausal women.
Methods: Estradiol buccal tablets containing 0.05, 0.1, 0.2, or 0.4 mg or placebo were administered for 28 days to 99 postmenopausal women in a randomized,
double-blind study; 19 premenopausal women were studied concurrently for comparison
of laboratory data. Objective and subjective assessments of HFF were obtained along
with measures of estradiol, estrone, follicle-stimulating hormone (FSH), and luteinizing
hormone (LH).
Results: Measurements of HFF revealed significant decreases from baseline in all estradiol
groups (P<0.01). In the 0.4 mg group, HFF decreased significantly compared to placebo (P<0.01). All estradiol doses produced similar improvement in the vaginal maturation
index. Mean serum estradiol levels increased as doses increased but were lower than
in the premenopausal subjects. Mean serum FSH and LH levels decreased in all estradiol
groups but not to the levels of the premenopausal subjects; the greatest decrease
occurred at the two highest estradiol doses.
Conclusion: A numerical dose–response relationship with hot flushes was seen in this pilot study
comparing 0.05, 0.1, 0.2, and 0.4 mg buccal estradiol. Only 0.4 mg 17-β estradiol significantly reduced the occurrence of hot flushes compared to
placebo.
Keywords
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Article info
Publication history
Accepted:
December 18,
2003
Received in revised form:
December 8,
2003
Received:
January 6,
2003
Identification
Copyright
© 2004 Elsevier Ireland Ltd. Published by Elsevier Inc. All rights reserved.
