CYCLOGEST

What it is

Cyclogest contains micronized progesterone 400 mg in hard fat. It is supplied as vaginal pessaries that are opaque, bullet-shaped waxy, solid masses.

Approved indications

— Assisted reproductive technology (ART) treatment of infertile women with progesterone deficiency, requiring progesterone supplementation or replacement to support embryo implantation and maintain initial pregnancy.

Dosing overview

For assisted reproductive technology, the usual dose of progesterone to support embryo implantation and maintain pregnancy is 200 mg daily to a maximum of 400 mg twice a day. Treatment duration is usually continued if the patient is pregnant, up to about the eleventh week of gestation. The pessary should be inserted deep into the vagina while in a squatting position or lying on back or side, with a preferable time of dosing at night before retiring.

Key safety warnings

Cyclogest should be used with caution and careful monitoring in conditions that might be aggravated by fluid retention, such as asthma, seizure disorders, migraine, or cardiac or renal dysfunction. A history of mental depression requires discontinuation if serious depression recurs during therapy. Diabetic patients require monitoring as high doses of progesterone therapy can lower glucose tolerance in some patients. Patients with hyperlipidemia require monitoring as progesterone may increase low density lipoprotein (LDL) and lower high density lipoprotein (HDL) levels. Caution should be exercised when driving a motor vehicle or operating machinery as dizziness or drowsiness may occur.

Contraindications

Cyclogest is contraindicated in patients with sensitivity to progesterone or hard fat, undiagnosed vaginal bleeding, undiagnosed urinary tract bleeding, liver dysfunction or disease, active thrombophlebitis or thromboembolic disorder (deep vein thrombosis or pulmonary embolism) or a history of hormone-associated thrombophlebitis or thromboembolic disorder, known or suspected malignancy of the breast or genital organs, or missed abortion or ectopic pregnancy. Progesterone is contraindicated in pregnancy during assisted reproductive technology treatment when normal progesterone levels are present.

PBS listing

In July 2022, the PBAC recommended Cyclogest for infertility (luteal phase support as part of an assisted reproductive technology treatment cycle for infertile women).

Regulatory history

Cyclogest was first approved in December 2003. Cyclogest progesterone 400 mg pessary was listed on the ARTG on 11 February 2022. The PBAC recommended the medicine in July 2022 for infertility as luteal phase support in assisted reproductive technology treatment cycles.