Abstract

The aim of the study was to determine the endometrial safety of oral 17/3- oestradiol combined continuously with dydrogesterone in preventing endometrial proliferation. The low dose group comprised three 52-week (13 cycles of 28 days) studies (two of which were double blind) using a 17ft- о estradiol dose of 1 mg daily combined with dydrogesterone 2,5; 5; 10 or 20 mg daily. The high dose group comprised two 24-week double-blind studies using a 17ft-oestradiol dose of 2 mg daily combined with dydrogesterone 2,5; 5; 10 or 15 mg daily. Endometrial safety was verified by aspiration endometrial biopsies. Inadequate progestational response was defined as proliferative endometrium, endometrial polyp, hyperplasia and carcinoma. Endometrial protection was achieved with dydrogesterone at doses of 5 mg or higher combined with 1 or 2 mg 17^-oestradiol. So, 5 mg daily dydrogesterone appears to be the lowest effective dose to ensure endometrial safety in a continuous combined regimen with 1 or 2 mg 17p-oestradiol.

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