Continuous combined hormone replacement therapy with 1 mg 17beta-oestradiol and 5 mg dydrogesterone (Femoston-conti): endometrial safety and bleeding profile.
OBJECTIVE
The aim of the study was to confirm the endometrial safety and describe the bleeding profile of continuous combined 1 mg 17beta-oestradiol and 5 mg dydrogesterone in post-menopausal women.


METHODS
An open, multicentre study was carried out in 290 healthy, non-hysterectomised post-menopausal women receiving oral continuous combined 1 mg 17beta-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.


RESULTS
Only 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.


CONCLUSIONS
Continuous combined 1 mg 17beta-oestradiol and 5 mg dydrogesterone provides excellent endometrial safety and is associated with an acceptable bleeding profile.
Quereux
C
C
Institut Mère-Enfant Alix de Champagne, Obstetrics and Gynaecology Department, 45 rue Cognac-Jay, 51092 Reims Cedex, France. cquereux@chu-reims.fr
Pornel
B
B
Bergeron
C
C
Ferenczy
A
A
D000368:Aged; D003430:Cross-Sectional Studies; D004338:Drug Combinations; D064420:Drug-Related Side Effects and Adverse Reactions; D004394:Dydrogesterone / Q000008:administration & dosage* / Q000009:adverse effects; D004717:Endometrium / Q000187:drug effects*; D004958:Estradiol / Q000008:administration & dosage* / Q000009:adverse effects; D015914:Estrogen Replacement Therapy; D005260:Female; D006801:Humans; D008875:Middle Aged; D017698:Postmenopause; D016896:Treatment Outcome; D014592:Uterine Hemorrhage / Q000139:chemically induced*
D004338:Drug Combinations; D004958:Estradiol; D004394:Dydrogesterone