ENDOMETRIN

What it is

ENDOMETRIN contains 100 mg of micronized progesterone in hard fat, presented as vaginal pessaries. Progesterone is a naturally occurring female sex hormone that acts on the endometrium by converting the proliferative phase induced by oestrogen to a secretory phase.

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. — Prevention of preterm birth in singleton pregnancies at risk due to shortened cervix (midtrimester sonographic cervix ≤25 mm) and/or where there is a history of spontaneous preterm birth.

Dosing overview

For ART treatment, duration is usually continued if the patient is pregnant, up to about the eleventh week of gestation. Other intravaginal therapies should not be used while progesterone pessary treatment is being undertaken.

Key safety warnings

Conditions that might be aggravated by fluid retention (such as asthma, seizure disorders, migraine, or cardiac or renal dysfunction) require use with caution and careful monitoring. History of mental depression warrants careful monitoring; discontinue if serious depression recurs during therapy. Diabetic patients require monitoring as high doses of progesterone therapy can lower glucose tolerance in some patients. Progesterone may increase low density lipoprotein (LDL) and lower high density lipoprotein (HDL) levels and aggravate problems in controlling hyperlipidemia. There is consistent evidence from several clinical trials and meta-analysis that supplementation with vaginal progesterone does not reduce risk of preterm birth or improve perinatal outcome in women with twin or multiple gestations. Efficacy and safety in pregnancies with 'threatened preterm labour' or 'other' risk factors for preterm birth has not been established. Use caution when driving a motor vehicle or operating machinery as dizziness or drowsiness may occur.

Contraindications

ENDOMETRIN is contraindicated in 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, pulmonary embolism) or a history of hormone-associated thrombophlebitis or thromboembolic disorder; known or suspected malignancy of the breast or genital organs; and missed abortion or ectopic pregnancy. Progesterone is contraindicated in pregnancy during ART treatment when normal progesterone levels are present.

PBS listing

ENDOMETRIN 100 mg vaginal tablet is listed on the PBS with streamlined restriction at an ex-manufacturer price of A$31.21.

Regulatory history

ENDOMETRIN pessaries 100 mg were first listed on the ARTG on 19 September 2012. The submission was approved on 3 September 2012 for luteal support in ART treatment. The TGA concluded that the product met acceptable standards for quality and nonclinical safety.