Clinical evaluation, dose-finding and acceptability of AERODIOL®

Clinical evaluation, dose-finding and acceptability of AERODIOL®, the pulsed estrogen therapy for treatment of climacteric symptoms
Clara Pelissier a,*, Anne de Kervasdoue b, Van Tuan Chuong c,
Eve-Laure Maugis d, Franc ̧ oiseValleteau de Mouillac b, Marie-He ́ le` ne Breil e,
Ge ́ rard Moniot f, Genevie` ve Zeitoun-Lepvrier g, Marc Robin b, Be ́ atrice Rime h
a
Department of Obstetrics and Gynecology, Hopital Hotel Dieu, Paris, France
b
Paris, France
c
Department of Obstetrics and Gynecology, Hopital Bichat, Paris, France
d
Asnie` res, France
e
Boulogne, France
f
Argenteuil, France
g
Department of Obstetrics and Gynecology, Hopital Port Royal, Paris, France
h
Rambouillet, France
Received 28 December 1999; accepted 10 October 2000

Abstract
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 ug for 12 weeks. The doses of 100, 600 and
900 ug were given in two daily administrations, the doses of 200, 300 and 450 ug 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-hysterectornized 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 g daily. Hormonal impregnation was judged
sufficient in 23% of women receiving the lowest dose (100 g). It was often considered excessive for daily doses of 900
g (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 g 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. © 2001 Elsevier Science Ireland Ltd. All rights reserved.