Estradiol and drospirenone for climacteric symptoms in postmenopausal women: a double-blind, randomized, placebo-controlled study of the safety and efficacy of three dose regimens
Abstract
METHOD: A randomized, placebo-controlled trial was conducted to evaluate the safety and efficacy of drospirenone (1, 2 or 3 mg) combined with estradiol (1 mg) in the treatment of climacteric symptoms in healthy postmenopausal women. RESULTS: The frequency of hot flushes was significantly decreased in all treatment groups (range 86-90%) in comparison to placebo (45%, p < or = 0.001) and remained suppressed at 16 weeks. Treatment with drospirenone and estradiol also decreased the intensity and severity of sweating, sleep problems, depression, nervousness, and urogenital symptoms. Most adverse events were mild or moderate, with similar rates observed in all groups. No serious adverse events or clinically significant laboratory abnormalities attributed to treatment occurred. CONCLUSION: These results demonstrate that the combinations of 1, 2, and 3 mg drospirenone with 1 mg estradiol are safe and effective for the treatment of climacteric symptoms.
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Several studies comparing hormone therapy to placebo have found that hormone therapy improves perceived sleep quality and self-reported sleeping problems more than placebo.
“Although several studies comparing HT to a placebo have found that HT improves perceived sleep quality and self-reported sleeping problems more than a placebo [112-123]”
From Non-Pharmacological Treatment of Insomnia (2012) · cites this paper as [115]
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References 13 · Cited by 69
- Authors
- Schürmann, R., Holler, T., & Benda, N.
- ORCID
- Benda, N
- Venue
- Climacteric
- Publisher
- Informa UK Limited
- Published
- 2004-06
- Volume
- 7
- Issue
- 2
- Pages
- 189-196
- ISSN
- 1369-7137 (ISSN-L)
- 1473-0804
- OpenAlex
- W2069197465
- Cited by
- 69
- References
- 13
- Citations by year
- 2026: 2 · 2025: 1 · 2023: 1 · 2020: 2 · 2019: 1 · 2018: 2 · 2017: 4 · 2016: 3 · 2015: 2 · 2014: 2 · 2013: 6 · 2012: 2
- FWCI
- 5.19
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Climacteric (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Menopause: Health Impacts and Treatments
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Estrogen and related hormone effects
- Health Sciences › Medicine › Psychiatry and Mental health › Sexual function and dysfunction studies
- Keywords
- drospirenone, estradiol, menopausal symptoms, postmenopausal women, hot flashes, hormone replacement therapy, dosing regimen, adverse events, urogenital symptoms, sleep disorders, depression
- MeSH terms
- Aged, Mineralocorticoid Receptor Antagonists, Androstenes, Double-Blind Method, Drug Administration Schedule, Drug Therapy, Combination, Estradiol, Female, Humans, Middle Aged, Treatment Outcome, Postmenopause, Hot Flashes
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