Rankings / Hormones & Endocrine

Estetrol (E4) for menopause

Hormones & Endocrine · Native estrogen (NEST)

Tier B

estrogenmenopausehrtnative-estrogeninvestigationalprescription
6.6 / 10
Tier B
Ev 8 Bn 6.5 Sf 5

Bottom line

Read Off Label grades Estetrol (E4) for menopause as B (6.6/10) based on strong evidence, med-high benefit magnitude, and a med-risk safety profile.

Estetra/Mithra (Donesta; licensed to Gedeon Richter).

Typical use: Oral 15-20 mg/day (menopause trials) — Rx.

What this is

Estetra/Mithra (Donesta; licensed to Gedeon Richter). E4COMFORT I and II Phase 3 (n~640): significant reductions in moderate-severe vasomotor symptom frequency and severity at weeks 4 and 12 vs placebo. Already approved as the contraceptive Nextstellis/Drovelis. Menopause launch expected 2026, an option for women with synthetic-HRT contraindications. Industry-sponsored.

Mechanism

Estetrol, a native fetal estrogen with tissue-selective estrogen-receptor activity and minimal hepatic impact, apparently with lower thrombotic-marker effect than synthetic or conjugated estrogens.

Dose & route

Oral 15-20 mg/day (menopause trials)

Citations

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Common questions

Does Estetrol (E4) for menopause work?
Read Off Label rates the evidence for Estetrol (E4) for menopause as Strong and the benefit magnitude as med-high, producing an overall grade of B (6.6/10). Estetra/Mithra (Donesta; licensed to Gedeon Richter).
Is Estetrol (E4) for menopause safe?
Estetrol (E4) for menopause has a med risk profile in published human data. Legal status: Rx (approved as contraceptive; menopause indication Phase 3 / filing). This is not medical advice — see the disclaimer.
What is the typical dose for Estetrol (E4) for menopause?
Oral 15-20 mg/day (menopause trials)
How does Estetrol (E4) for menopause work?
Estetrol, a native fetal estrogen with tissue-selective estrogen-receptor activity and minimal hepatic impact, apparently with lower thrombotic-marker effect than synthetic or conjugated estrogens.

This is an independent synthesis of published research by a non-clinician. Scores are opinions supported by citations, not prescriptions. See the full disclaimer and methodology for how this score was produced and what it does and doesn't mean.