ESTROGEL

What it is

ESTROGEL is an estradiol (as hemihydrate) 0.06% w/w gel supplied in a pump pack.

Approved indications

— Short term treatment of symptoms of estrogen deficiency due to the menopause, whether natural or surgically induced.

Dosing overview

Treatment is usually initiated with an Estradot 50 patch. Depending on the clinical response the dose should then be adjusted to the woman's individual needs. If, after three months, there is an insufficient response in the form of alleviated symptoms, the dose should be increased. Maintenance therapy must always be at the lowest effective dose.

Key safety warnings

Estrogens with or without progestogens should not be used for the prevention of cardiovascular disease or dementia. The Women's Health Initiative study reported increased risks of stroke and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 6.8 years of treatment with conjugated estrogens relative to placebo. The Women's Health Initiative study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5 years of treatment with conjugated estrogens combined with medroxyprogesterone acetate relative to placebo. The use of estrogens and progestogens by postmenopausal women has been reported to increase the risk of breast cancer. After a mean follow-up of 5.6 years, the Women's Health Initiative trial reported an increased risk of breast cancer in women who took estrogen plus progestogen. The use of unopposed estrogens in women with intact uteri has been associated with an increased risk of endometrial cancer. The reported endometrial cancer risk among unopposed estrogen users with an intact uterus is about 2- to 12-fold greater than in non-users, and appears dependent on duration of treatment and on estrogen dose. The Women's Health Initiative Memory Study reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 to 5.2 years of treatment with conjugated estrogens, with or without medroxyprogesterone acetate, relative to placebo.

Contraindications

Contraindications include known, past or suspected carcinoma of the breast; known or suspected carcinoma of the endometrium or other estrogen-dependent neoplasia; undiagnosed abnormal vaginal bleeding; severe hepatic impairment; active venous thromboembolism or documented history of thromboembolic disorders; porphyria; known or suspected pregnancy; breast-feeding; and known hypersensitivity to estrogens or any other component of the patch. Non-hysterectomised women unless on concomitant progestogen therapy.

PBS listing

ESTROGEL transdermal gel (pump pack) 750 micrograms per 1.25 g dose, 64 doses, is listed on the PBS with unrestricted and restricted benefit listings, with an ex-manufacturer price of A$21.16.

Regulatory history

ESTROGEL estradiol 0.06% w/w gel pump pack was first listed on the ARTG on 2019-05-08. In November 2024, the PBAC recommended ESTROGEL for unrestricted benefit listings on the General Schedule for menopausal hormone therapy, and corresponding restricted benefit listings for 60-day maximum dispensed quantities.