Clinical evaluation, dose-finding and acceptability of AERODIOL, the pulsed estrogen therapy for treatment of climacteric symptoms.
S21400 (AERODIOL) is a new intranasal formulation of 17beta-estradiol. It provides a pulsed estrogen therapy that ensures sufficient estrogenisation of tissues to treat estrogen deficiency symptoms, particularly those of the menopause. This multicentric study was designed to determine dose-range, efficacy and acceptability of S21400. One hundred and thirty four women were allocated a daily dose of 100-900 microg for 12 weeks. The doses of 100, 600 and 900 microg were given in two daily administrations, the doses of 200, 300 and 450 microg were given in one and two daily administrations. Oral progestogen was added the last 10-14 days of each cycle of estrogen therapy in all non-hysterectomized women. S21400 showed a dose-effect relationship and provided adequate estrogenisation in more than 80% of patients receiving a dose ranging from 200 to 600 microg daily. Hormonal impregnation was judged sufficient in 23% of women receiving the lowest dose (100 microg). It was often considered excessive for daily doses of 900 microg (36%). After 12 weeks of treatment, efficacy was similar whether the total daily dose was given in one or two administrations. Treatment was well tolerated and accepted, with only minor nasal events (prickling, sneezing). It was perceived by 92% of patients as good or excellent and 81% chose to continue the nasal treatment when it was offered to them. An initial dose of 300 microg per day provides an optimal efficacy/tolerability ratio. In summary, the pulsed estrogen therapy with AERODIOL in one daily administration offers a safe, well accepted and highly effective treatment to alleviate climacteric symptoms. It can be adapted easily to ensure optimal clinical efficacy.
Pelissier
C
C
Department of Obstetrics and Gynecology, Hopital Hotel Dieu, Paris, France.
de Kervasdoue
A
A
Chuong
V T
VT
Maugis
E L
EL
de Mouillac
F
F
Breil
M H
MH
Moniot
G
G
Zeitoun-Lepvrier
G
G
Robin
M
M
Rime
B
B
D000280:Administration, Inhalation; D000328:Adult; D002979:Climacteric / Q000187:drug effects*; D004305:Dose-Response Relationship, Drug; D004958:Estradiol / Q000008:administration & dosage*; D005260:Female; D005602:France; D020249:Hormone Replacement Therapy; D006801:Humans; D008875:Middle Aged; D010349:Patient Compliance; D017060:Patient Satisfaction; D020551:Pulse Therapy, Drug
D004958:Estradiol