Dydrogesterone

What it is and how it works

Dydrogesterone is an orally active progestogen structurally related to progesterone that acts selectively on progesterone receptors in the endometrium, producing secretory transformation. It has no significant oestrogenic, androgenic, glucocorticoid or thermogenic activity and does not inhibit ovulation at usual doses.

Indications

Conditions associated with progesterone deficiency, including dysmenorrhoea, endometriosis, secondary amenorrhoea, irregular cycles, dysfunctional uterine bleeding, premenstrual syndrome, threatened and habitual miscarriage associated with proven progestogen deficiency, luteal support in assisted reproduction, and endometrial protection in hormone replacement therapy.

Dosage and administration (summary)

Usually 10 mg orally one to three times daily, with the dose, timing in the cycle and duration depending on the indication.

Contraindications

Known or suspected progestogen-dependent neoplasms (e.g. meningioma), undiagnosed vaginal bleeding, severe hepatic disease or liver tumours; when combined with an oestrogen, the contraindications of oestrogen therapy also apply.

Warnings and precautions

Breakthrough bleeding should be investigated. Use with caution in patients with a history of depression, porphyria or hepatic impairment; liver function abnormalities have been reported rarely.

Pregnancy

Has been used in early pregnancy for threatened or recurrent miscarriage with proven progestogen deficiency; use only where clearly indicated.

Storage and supply

Store below 30 °C.

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.