PROGESTERONE

What it is

Progesterone ADVZ is a soft capsule containing micronised progesterone 100 mg or 200 mg. The capsules contain soy bean lecithin as an excipient with known effect. Progesterone ADVZ 100 are ovoid soft gelatin capsules, off-white coloured containing a thick whitish suspension, approximately 12 mm long and 8 mm wide, whilst Progesterone ADVZ 200 are approximately 16 mm long and 9.6 mm wide.

Approved indications

— Treatment of menstrual irregularities in women with menstrual abnormalities or secondary amenorrhoea due to normogonadotrophic amenorrhoea. — Hormone replacement therapy as adjunctive use with an oestrogen in postmenopausal women with an intact uterus.

Dosing overview

For hormone replacement therapy, progesterone 200 mg daily at bedtime should be administered for twelve days in the last half of each therapeutic cycle (beginning on day 15 of the cycle and ending on day 26), or alternatively, 100 mg can be given at bedtime from day 1 to day 25 of each therapeutic cycle. In women with secondary amenorrhoea, the treatment may be given as a single daily dose of 400 mg (two capsules 200 mg) at bedtime for 10 days. In menstrual irregularities due to ovulation disorders or anovulation, the treatment is administered over 10 days per menstrual cycle, usually from cycle days 17 to 26 inclusive.

Key safety warnings

Progesterone ADVZ is not a treatment for premature labour. During pregnancy, progesterone should only be used during the first three months and only by the vaginal route. Cases of cytolytic liver damage and cases of gravidic cholestasis were exceptionally reported during the administration of micronised progesterone during the 2nd and 3rd trimesters of pregnancy. Use of Progesterone ADVZ as hormone replacement therapy is associated with an increased risk of developing deep vein thrombosis (DVT) or pulmonary embolism. There is suggestive evidence of a small increased risk of breast cancer with oestrogen replacement therapy, and it is not known whether concurrent progesterone influences the risk of cancer in postmenopausal women taking hormone replacement therapy. Progesterone ADVZ contains soya bean lecithin which may cause hypersensitivity reactions including urticaria and anaphylactic shock. Cases of drowsiness and dizzy sensations have been reported, and drivers and machine operators in particular are alerted to the risks of drowsiness and dizziness associated with oral use of this medicine.

Contraindications

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

Regulatory history

Progesterone ADVZ 100 and Progesterone ADVZ 200 were first listed on the Australian Register of Therapeutic Goods on 20 October 2025. In November 2020, the Pharmaceutical Benefits Scheme Advisory Committee recommended progesterone for prevention of preterm birth.