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.