A multicenter, randomized study to select the minimum effective dose of estetrol (E4) in postmenopausal women (E4Relief): part 1. Vasomotor symptoms and overall safety
Open accessAbstract
OBJECTIVE: The aim of this study was to select the minimum effective dose of estetrol (E4) for the treatment of vasomotor symptoms in postmenopausal women. METHODS: This was a multicenter, randomized, double-blind, placebo-controlled study. Postmenopausal women (n = 257, of whom 32 were hysterectomized) aged 40 to 65 years, with ≥7 moderate to severe hot flushes (HFs) per day, or 50 or more moderate to severe HFs weekly, received 2.5, 5, 10, or 15 mg E4, or placebo once-daily for a period of 12 weeks. Efficacy was assessed by recording the frequency and severity of HFs. Overall safety was assessed by recording adverse events, measuring endometrial thickness, and monitoring bleeding patterns. Treatment groups were compared using analysis of covariance. RESULTS: The frequency of moderate to severe HFs decreased with all E4 doses. The difference in the percentage change of weekly HF frequency was significant for 15 mg E4 versus placebo at both W4 (-66% vs -49%, P = 0.032) and W12 (-82% vs -65%, P = 0.022). The decrease in severity of HFs was significantly more pronounced for 15 mg E4 than for placebo at both W4 (-0.59 vs -0.33, P = 0.049) and W12 (-1.04 vs -0.66, P = 0.049); the other doses failed to achieve statistical significance. In nonhysterectomized women, endometrial thickness increased during treatment and normalized following progestin treatment at study completion. No endometrial hyperplasia was observed. CONCLUSIONS: Estetrol 15 mg is considered to be the minimum effective daily oral dose for treatment of vasomotor symptoms. Its current seemingly favorable safety profile is further to be confirmed in phase 3 clinical development. : Video Summary:http://links.lww.com/MENO/A591.
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Chemically synthesized E4 is identical to the natural hormone.
“Chemically synthesized E4 is identical to the natural hormone and has been studied in contraception, menopause, osteoporosis, and breast cancer [9-11] .”
From Endocrine and metabolic effects of an oral contraceptive containing estetrol and drospirenone (2021) · cites this paper as [10]
The paper describes E4 as a native estrogen (Abstract > Conclusions) and identifies the E4 administered in the trial (Methods > Treatments). It does not state that the administered E4 was chemically synthesized or establish its chemical identity with naturally occurring E4. (LLM, conf=0.77)
Experimental — accuracy not yet measuredE4 has been studied in contraception, menopause, osteoporosis, and breast cancer.
“Chemically synthesized E4 is identical to the natural hormone and has been studied in contraception, menopause, osteoporosis, and breast cancer [9-11] .”
From Endocrine and metabolic effects of an oral contraceptive containing estetrol and drospirenone (2021) · cites this paper as [10]
The Methods and Results describe an E4 trial for menopausal hot flushes, and the References cite an E4 study in an osteoporosis model. The copy does not establish that E4 has been studied in contraception or breast cancer; its breast-related reference concerns mammary-gland proliferation, not breast cancer. (LLM, conf=0.84)
Experimental — accuracy not yet measured
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Percentages, sums and reported differences re-computed from the paper’s own numbers.
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- Authors
- Gaspard, U., Taziaux, M., Mawet, M., Jost, M., Gordenne, V., Coelingh Bennink, H. J. T., Lobo, R. A., Utian, W. H., & Foidart, J.-M.
- Affiliations
- University of Liège (BE)
- Mithra Pharmaceuticals (Belgium) (BE)
- Pantarhei Bioscience, Zeist, The Netherlands
- Columbia University Medical Center, New York, NY
- Case Western Reserve University (US)
- Corresponding author
- Jost, Maud
- Venue
- Menopause
- Published
- 2020-05-05
- Volume
- 27
- Issue
- 8
- Pages
- 848-857
- ISSN
- 1072-3714 (ISSN-L)
- 1530-0374
- PMC
- PMC7386865
- OpenAlex
- W3023230046
- Cited by
- 52
- References
- 28
- Citations by year
- 2026: 4 · 2025: 9 · 2024: 10 · 2023: 9 · 2022: 10 · 2021: 7 · 2020: 3
- FWCI
- 5.47
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Menopause The Journal of The North American Menopause Society (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- ORBi (University of Liège) (submittedVersion, cc-by-nc-nd)
- Funders
- Waalse Gewest
- 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 › Pathology and Forensic Medicine › Phytoestrogen effects and research
- Keywords
- estetrol, E4, minimum effective dose, hot flashes, vasomotor symptoms, postmenopausal women, hormone replacement therapy, endometrial thickness, endometrial hyperplasia, bleeding patterns, progestins, drug safety
- MeSH terms
- Adult, Aged, Double-Blind Method, Endometrial Hyperplasia, Estetrol, Estrogens, Female, Humans, Middle Aged, Treatment Outcome, Postmenopause, Hot Flashes
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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