A short study in the treatment of hot flashes with buccal administration of 17-beta estradiol.
OBJECTIVE
To assess the efficacy and safety of 17-beta 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.


CONCLUSIONS
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-beta estradiol significantly reduced the occurrence of hot flushes compared to placebo.
Gass
Margery S
MS
Department of Obstetrics and Gynecology, University of Cincinnati College of Medicine, Cincinnati, OH, USA. margery.gass@uc.edu
Rebar
Robert W
RW
Cuffie-Jackson
Cynthia
C
Cedars
Marcelle I
MI
Lobo
Rogerio A
RA
Shoupe
Donna
D
Judd
Howard L
HL
Buyalos
Richard P
RP
Clisham
Paul R
PR
D000278:Administration, Buccal; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D004958:Estradiol / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood; D015914:Estrogen Replacement Therapy / Q000379:methods*; D005260:Female; D005640:Follicle Stimulating Hormone / Q000097:blood; D019584:Hot Flashes / Q000188:drug therapy*; D006801:Humans; D007986:Luteinizing Hormone / Q000097:blood; D008875:Middle Aged; D010865:Pilot Projects; D017698:Postmenopause; D016896:Treatment Outcome
D004958:Estradiol; D007986:Luteinizing Hormone; D005640:Follicle Stimulating Hormone