Continuous combined hormone replacement therapy with 1 mg 17β-oestradiol and 5 mg dydrogesterone (Femoston®-conti): Endometrial safety and bleeding profile

ObjectivesThe aim of the study was to confirm the endometrial safety and describe the bleeding profile of continuous combined 1 mg 17β-oestradiol and 5 mg dydrogesterone in post-menopausal women.MethodsAn open, multicentre study was carried out in 290 healthy, non-hysterectomised post-menopausal women receiving oral continuous combined 1 mg 17β-oestradiol and 5 mg dydrogesterone (Femoston®-conti) for 1 year. Aspiration endometrial biopsies were performed at baseline and at the end of the study; those classified as hyperplasia or malignancy were considered treatment failures.ResultsOnly one woman developed simple hyperplasia without atypia at the end of the study; the treatment failure rate was therefore 0.4%. Cross-sectional analysis showed that the percentage of women without bleeding increased from 71% during the first cycle to around 80% by the end of the study. Approximately 50% of the bleeding episodes occurred in the form of spotting; severe bleeding was rare and only seven women withdrew prematurely from the study due to uterine bleeding. Overall, 41% of the women were amenorrhoeic throughout the study.ConclusionsContinuous combined 1 mg 17β-oestradiol and 5 mg dydrogesterone provides excellent endometrial safety and is associated with an acceptable bleeding profile.