Clinical evaluation, dose-finding and acceptability of AERODIOL®, the pulsed estrogen therapy for treatment of climacteric symptoms

S21400 (AERODIOL(R)) is a new intranasal Formulation of 17 beta -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 ar-id acceptability of S21400. One hundred and thirty four women were allocated a daily dose of 100-900 mug for 12 weeks. The doses of 100, 600 and 900 mug were given in two daily administrations. the doses of 100, 300 and 450 mug 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 mug daily. Hormonal impregnation was judged sufficient in 23% of women receiving the lowest dose (100 mug). It was often considered excessive for daily doses of 900 mug (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% chest to continue the nasal treatment when it was offered to them. An initial dose of 300 mug per day provides an optimal efficacy/tolerability ratio. In summary, the pulsed estrogen therapy with AERODIOL(R) 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. (C) 2001 Elsevier Science Ireland Ltd. All rights reserved.