The use of estradiol metered-dose transdermal spray in clinical practice

Abstract

Objective: The aim of this study was to evaluate the use of novel estradiol metered-dose transdermal spray (EMDTS) in the treatment of acute climacteric syndrome.

Methods: A multicenter open-label trial was conducted with a 24-week intervention. EMDTS 1.53 mg was given to symptomatic menopausal women. The Menopause Rating Scale (MRS) was used to assess the climacteric syndrome severity. The Friedman non-parametric test and a post-hoc test with Bonferroni correction were used for statistical evaluation.

Results: A total of 132 women were enrolled in 20 centers, of whom 123 (93.2%) completed the study. The average age of patients was 53.8 years (37–65 years). The study was discontinued by 6.8% of women. The patients were checked at the beginning of the study, and after 12 and 24 weeks. There was a statistically significant drop (p < 0.001) in MRS values both after 12 and 24 weeks of therapy. The average MRS values improved by 66.2% between the first and the third visits. The most significant improvement was manifested in patients with initial moderate climacteric syndrome (70.9%).

Conclusion: This study confirms that application of EMDTS offers a novel treatment option for climacteric symptoms.

Keywords:

• Menopause
• climacteric syndrome
• vaginal dryness
• estradiol metered-dose transdermal spray

Conflict of interest

No potential conflict of interest was reported by the authors.

Source of funding

The study was supported by an educational grant from the Czech Menopause and Andropause Society.

Table 1. Menopause Rating Scale.