PROGYNOVA

What it is

PROGYNOVA contains estradiol valerate which is a prodrug of the natural human 17β-estradiol. PROGYNOVA is available in two strengths: 1 mg and 2 mg tablets.

Approved indications

— Short term treatment of climacteric complaints after the cessation of monthly bleeding, or deficiency symptoms after oophorectomy or radiological castration for non-carcinomatous diseases, such as hot flushes, outbreaks of sweat, sleep disturbances, depressive moods, irritability, headaches, and dizziness. — PROGYNOVA also has a favourable influence on bladder irritation and signs of cutaneous and mucosal involution, particularly in the genital region.

Dosing overview

Unless otherwise prescribed by the doctor, one PROGYNOVA tablet is taken daily (either one 1 mg tablet or one 2 mg tablet) and the tablets are to be swallowed whole with some liquid. Each pack covers 28 days and treatment is continuous, which means that the next pack follows immediately without a break. It is mandatory to add a progestogen for the last 10–14 days of each month of therapy.

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 aged 50 to 79 years during 6.8 years of treatment with conjugated estrogens relative to placebo. The same study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women aged 50 to 79 years during 5 years of treatment with conjugated estrogens combined with medroxyprogesterone acetate relative to placebo. 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. Because of these risks, estrogens with or without progestogens should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman. High-dosed and long-term use of unopposed estrogens during the climacteric may increase the incidence of endometrial carcinoma. In some studies, the use of estrogens and progestogens by postmenopausal women has been reported to increase the risk of breast cancer.

Contraindications

PROGYNOVA should not be started in the presence of pregnancy and lactation, undiagnosed vaginal bleeding, known or suspected cancer of the breast, known or suspected premalignant conditions or malignancies if sex steroid-influenced, presence or history of liver tumours, severe hepatic disease, acute arterial thromboembolism, active deep vein thrombosis or thromboembolic disorders, high risk of venous or arterial thrombosis, severe hypertriglyceridemia, idiopathic cholestatic jaundice of pregnancy, otosclerosis with deterioration during pregnancy, severe diabetes with vascular changes, or known hypersensitivity to any of the components of PROGYNOVA.

PBS listing

The 2 mg tablet formulation is listed on the PBS under 2 items with restrictions, at an ex-manufacturer price of A$4.14.

Regulatory history

PROGYNOVA 1 mg tablets were first registered on the Australian Register of Therapeutic Goods on 19 August 1991. PROGYNOVA 2 mg tablets were first listed on 6 February 2020. In November 2017, the PBAC recommended the product for oral contraception.