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April 30, 2026Maturitas2 citationsOpen Access

Estetrol (E4) for the treatment of moderate to severe vasomotor symptoms in postmenopausal women – Efficacy and safety results from the phase 3 E4COMFORT I multicenter, placebo-controlled trial

TSTommaso SimonciniCBCéline BouchardMCMarie Cloes

Key Points

  • This trial aimed to evaluate the efficacy and safety of estetrol (E4) in treating moderate to severe vasomotor symptoms in postmenopausal women.
  • Multicenter, placebo-controlled trial
  • Assessed efficacy at 15 mg and 20 mg doses of E4
  • Follow-up duration from week 4 to week 12
  • E4 significantly reduced vasomotor symptom frequency and severity by week 12
  • Both 15 mg and 20 mg doses showed notable benefit
  • E4 treatment was well tolerated with low discontinuation rates

Abstract

Highlights Estetrol (E4) reduced the frequency and severity of vasomotor symptoms from week 4 to week 12 in postmenopausal women in the E4COMFORT I placebo-controlled trial. Significant benefits were observed with both 15 mg and 20 mg doses of E4. E4 treatment was well tolerated, with low discontinuation rates. These findings support the use of E4 in symptomatic postmenopausal women.

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Cite This Study

Simoncini et al. (2026) studied this question.

synapsesocial.com/papers/69f2f19c1e5f7920c63873b7https://doi.org/10.1016/j.maturitas.2026.108965
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