Estetrol for Menopause: Four Fylrevy Evidence Checks

Estetrol, also called E4, now appears in menopause-treatment headlines. Before comparing it with an existing prescription, separate the authorized product from the study dose names and check which precautions apply to your medical history.

Check the jurisdiction and patient group

Fylrevy received EU marketing authorization on March 26, 2026.¹ The European indication covers postmenopausal estrogen-deficiency symptoms after hysterectomy, or with a uterus at least 12 months after the last period.²

That wording matters if your periods are still occurring. An EU authorization also does not establish that a pharmacy in another country can supply the medicine. Ask about the exact local product rather than ordering from a headline.

Read the hot-flash result as a weekly difference

E4COMFORT I randomized 640 participants aged 40–65 to the study’s 15 mg, 20 mg or placebo groups for 12 weeks. At week 12, the adjusted differences versus placebo were 16.41 and 22.49 fewer moderate-to-severe hot flashes per week, respectively, not per day or the entire reduction from baseline.³

Treatment-emergent adverse events led to discontinuation in 6.6%, 7.5% and 2.3%, respectively. Two authors were affiliated with Estetra, a Gedeon Richter subsidiary. This placebo comparison does not establish better efficacy or safety than an estradiol patch.³

Match the dose notation and the progestogen plan

The EMA assessment explains the notation: 15 mg estetrol monohydrate corresponds to 14.2 mg estetrol, and 20 mg monohydrate to 18.9 mg estetrol. These are different ways of expressing the studied ingredient amount, not instructions for converting another estrogen prescription.⁴

Fylrevy is estrogen-only; women with a uterus need continuous progestogen. The label flags bleeding and uterine-lining findings with 18.9 mg estetrol plus 100 mg progesterone. Higher progesterone doses or another approved progestogen may be used, but safety/tolerability data for those alternatives are unavailable.²

The appointment needs the complete regimen, including the second hormone. Do not infer that a newer estrogen removes the uterine-lining discussion.

Keep the safety screen beside the benefit

Contraindications include known, past or suspected breast cancer, unexplained genital bleeding, and previous or current deep-vein thrombosis or pulmonary embolism. Initiation after 65 has not been studied. Bleeding beginning after some time on treatment or continuing after stopping requires investigation.²

Bring your bleeding history, prior clots, cancer history and full medicine list. Ask which details affect suitability and what changes should prompt contact. The trial’s short placebo-controlled comparison cannot settle uncommon harms over years of use.³

Put both hormones on the page

In My Body Changed. Now What?, “The Hormone Question” explains why uterine status changes the estrogen/progestogen conversation. “Hormone Therapy, Briefly” covers how treatment type, dose, route, timing and progestogen use affect the decision. Use those sections to prepare questions about the proposed regimen, rather than treating E4 as a complete plan on its own.