17β-Estradiol/levonorgestrel transdermal system for the management of the symptomatic menopausal woman

Abstract

Recent publications of the initial outcomes from the Women’s Health Initiative (WHI) study of menopausal management have raised concerns over the safety of hormone therapy [1,2]. Every study, no matter how large or well conducted, has biases and limitations that preclude the ability to apply the outcomes to a larger group of individuals not specifically evaluated in the analysis. In particular, the hormonal arms of the WHI evaluated only a single dose of a daily oral regimen of conjugated equine oestrogen 0.625 mg [1,2], combined with medroxyprogesterone acetate 2.5 mg if the subject had a uterus [1]. The failure to evaluate non-oral regimens prevented the evaluation of hormone delivery systems that have been shown to provide similar symptom relief to oral regimens, but with a considerably different physiological impact. The once-weekly transdermal patch (Climara Pro™) releasing 17β-estradiol 0.045 mg/day and levonorgestrel 0.015 mg/day has been shown to be highly effective in rapidly reducing the frequency and intensity of vasomotor symptoms and to significantly improve all categories in the quality of life Women’s Health Questionnaire [3]. In addition, this transdermal combination system was not associated with any cases of endometrial hyperplasia, adverse impacts on cholesterol or lipid values and was associated with an increasing rate of amenorrhoea over time [3]. The 17β-estradiol/levonorgestrel transdermal system is approved in the US for the treatment of moderate-to-severe vasomotor symptoms and the prevention and treatment of urogenital atrophy.