UTROGESTAN

What it is

Utrogestan is a soft capsule formulation containing micronised progesterone, available in strengths of 200 mg, 300 mg, and 400 mg. The medicine is administered by vaginal insertion, with each capsule inserted deep into the vagina.

Approved indications —

Luteal support of Assisted Reproductive Technology (ART) cycles — Prevention of preterm birth in women with singleton pregnancy who have a short cervix (mid-trimester sonographic cervix ≤ 25 mm) and/or a history of spontaneous preterm birth — Treatment of unexplained threatened miscarriage in women with bleeding in the current pregnancy and a history of at least three or more previous miscarriages

Dosing overview

Key safety warnings

Cases of cytolytic liver damage and cases of gravidic cholestasis have been exceptionally reported during the administration of micronised progesterone during the 2nd and 3rd trimesters of pregnancy. Patients with a past history of venous thrombosis must be monitored closely. Utrogestan should be used cautiously in patients with conditions that might be aggravated by fluid retention such as hypertension, cardiac disease, renal disease, epilepsy, migraine, and asthma, as well as in patients with a history of depression, diabetes, mild to moderate hepatic dysfunction, and in breast-feeding mothers. Utrogestan contains soya lecithin which may cause hypersensitivity reactions including urticaria and anaphylactic shock.

Contraindications

Utrogestan should not be used in individuals with known allergy or hypersensitivity to progesterone or to any of the excipients, severe hepatic dysfunction, undiagnosed vaginal bleeding, known missed abortion or ectopic pregnancy, mammary or genital tract carcinoma, thromboembolic or thrombophlebitis disorders, cerebral haemorrhage, or porphyria.

PBS listing

Utrogestan 200 mg capsules are listed on the PBS with 2 items under a streamlined authority required restriction, with an ex-manufacturer price of A$75.53.

Regulatory history

Utrogestan 200 mg was first registered on the ARTG on 12 July 2016. In July 2016, the PBAC recommended listing for luteal phase support as part of an assisted reproductive technology treatment cycle under Section 100 (IVF Program) with streamlined authority required restriction. The 300 mg and 400 mg bottle formulations were first listed on the ARTG on 12 August 2024, and the 300 mg and 400 mg blister pack presentations were first listed on 2 July 2025. In March 2024, the PBAC considered the prevention of preterm birth indication.