Maturitas. 2001 Jun 15;38 Suppl 1:S15-22.

Dose-ranging studies of a novel intranasal estrogen replacement therapy.
Panay N , Toth K, Pelissier C, Studd J.

Lister Hospital, Chelsea Bridge Road, London SW1W 8RH, UK.

Objectives:

To study the efficacy and tolerability of Aerodiol, a novel intranasal estradiol spray, and to determine an appropriate dose range.

Methods:

An exploratory, parallel-group, dose-finding study was followed by a large-scale, double-blind, placebo-controlled study. In the exploratory study, 134 postmenopausal women were allocated to receive a daily dose of 100--900 microg of Aerodiol for 12 weeks. Efficacy was determined by an overall assessment of estrogenization. In the placebo-controlled study, 420 postmenopausal women were randomized to receive 100, 200, 300, or 400 microg of Aerodiol, or oral estradiol 1 or 2 mg, or placebo, daily for 12 weeks. Efficacy was assessed by the Kupperman Index and the number of hot flushes per day after 12 weeks.

Results:

In the exploratory study, the level of estrogenization was sufficient for 23% of women in the 100 microg/day group, excessive for 36% of the 900 microg/day group, and good for more than 80% of women receiving 200--600 microg/day. In the placebo-controlled study, the Kupperman Index at week 12 was significantly lower than placebo (P<0.01) for all Aerodiol groups except the 100 microg/day group. The efficacy of Aerodiol 300 microg/day was similar to oral estradiol 2 mg/day. The variability in exposure to estradiol was lower with Aerodiol than with oral estradiol. Aerodiol therapy was well tolerated in both studies. Premature withdrawals were approximately e qually distributed among treatment groups in the placebo-controlled study.

Conclusions:

Aerodiol was effective in reducing climacteric symptoms at doses between 100 and 600 microg/day. Treatment was well tolerated and well accepted. A dose of 300 microg/day is recommended for initiating hormone replacement therapy.

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2 How can atrophic vaginitis - dry vagina at menopause - painful sex - be treated? - Topical Estrogen

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