Low incidence of endometrial hyperplasia with acceptable bleeding patterns in women taking sequential hormone replacement therapy with dydrogesterone

Abstract

A meta-analysis was undertaken to assess the incidence of endometrial hyperplasia during sequentially combined oral 17β-estradiol and dydrogesterone (Femoston®) treatment in postmenopausal women. Bleeding pattern was assessed separately in each study. Two studies were double-blind, 6-month studies and two were open, long-term (1- or 2-year) studies. 17β-estradiol 2 mg daily was combined with dydrogesterone 10 mg for 14 days per 28-day cycle. Endometrial safety was assessed by endometrial biopsy in 369 women treated. In 236 women treated for one year or more, one simple hyperplasia was diagnosed (success rate: 99.61%; lower limit of one-sided 95% confidence interval: 98.16). The last observation carried forward analysis in 369 women also revealed one simple hyperplasia (success rate: 99.73%; lower limit of one-sided 95% confidence interval: 98.72). Cyclic bleeding occurred in approximately 90% of women; the duration and day of onset was highly predictable between cycles and the severity of bleeding was generally rated as slight. In conclusion, sequentially combined 17β-estradiol 2 mg and dydrogesterone 10 mg has very good endometrial safety and is associated with light and predictable bleeding of short duration.