Aerodiol® versus the transdermal route: perspectives for patient preference

Patrice Lopes a,*, Serge Rozenberg b, Jan de Graaf c, E. Fernandez-Villoria d,
L. Marianowski e
a
Hoˆ pital Me` re et Enfants, Serice de Gynecologie Obstetrique, 7 Quai Moncousu, 44093 Nantes Cedex 1, France
b
St Peter Hospital, Brussels, Belgium
c
Tilburg, The Netherlands
d
Fundacion Jimenez Diaz, Madrid, Spain
e
Warsaw, Poland

Abstract
Objectie: to compare the efficacy, tolerability and user preference of Aerodiol® intranasal and transdermal patch
administration of 17-estradiol for climacteric symptoms. Methods: an open-label, multicenter, crossover trial in
which recently postmenopausal women were randomized to receive either Aerodiol 300 g daily (n = 176), or
transdermal 17-estradiol (reservoir patches delivering 50 g/day), 2 patches per week (n = 185), for 12 weeks,
followed by 4 weeks of the alternative treatment. Efficacy was assessed primarily by the Kupperman index at the end
of each treatment period. User satisfaction was assessed by questionnaire at weeks 12 and 16, and at week 16 the
women chose which treatment they preferred to use for a further 40-week period. Results: Aerodiol and transdermal
patch therapy produced marked and similar reductions in the Kupperman index and the incidence of hot flushes at
weeks 12 and 16. The reduction in the Kupperman index at week 12 was statistically equivalent for the two
treatments. The tolerability of both treatments was good, with similar numbers of emergent adverse events reported
in both groups. The incidence of moderate or severe mastalgia, however, was significantly lower with Aerodiol
(P = 0.02). Significantly more women chose to continue treatment with Aerodiol than with the transdermal patch (66
vs. 34%, P 0.001). When all women had experienced both treatments, reported levels of satisfaction were
significantly higher with Aerodiol than with transdermal therapy (P 0.001 for all six categories assessed).
Conclusions: Aerodiol and transdermal patch treatments were of similar efficacy and tolerability. Levels of user
preference and satisfaction, however, were higher with Aerodiol, which should contribute towards good long-term
compliance with this therapy. © 2001 Elsevier Science Ireland Ltd. All rights reserved.
Keywords: Aerodiol; Estradiol; Kupperman index