The use of estradiol metered-dose transdermal spray in clinical practice
Language English Country Great Britain, England Media print-electronic
Document type Clinical Trial, Journal Article, Multicenter Study
- Keywords
- Menopause, climacteric syndrome, estradiol metered-dose transdermal spray, vaginal dryness,
- MeSH
- Administration, Cutaneous MeSH
- Adult MeSH
- Estradiol administration & dosage MeSH
- Estrogen Replacement Therapy * MeSH
- Middle Aged MeSH
- Humans MeSH
- Menopause drug effects MeSH
- Hot Flashes drug therapy MeSH
- Aged MeSH
- Severity of Illness Index MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial MeSH
- Multicenter Study MeSH
- Geographicals
- Czech Republic MeSH
- Names of Substances
- Estradiol MeSH
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.
References provided by Crossref.org
Menopause hormone therapy: latest developments and clinical practice