EFFECTS OF TRANSDERMAL ESTROGEN THERAPY IN POSTMENOPAUSAL WOMEN - A COMPARATIVE-STUDY OF AN ESTRADIOL GEL AND AN ESTRADIOL DELIVERING PATCH

Objective To compare the efficacy, safety and tolerability of an oestr adiol gel (1.0 mg of oestradiol daily, Divigel(R)/Sandrena(R)) with th ose of an oestradiol delivering patch (delivering 50 mu g oestradiol/2 4 h, Estraderm TTS(R)) in hormone replacement therapy of postmenopausa l women. Dydrogesterone tablets (Terolut(R)), 10 mg daily for the firs t 12 days of every month, were used as the progestogen component of th e therapy. Main outcome measures The effect of treatment on clinical s ymptoms and on endometrium, total body bone mineral density and lipid metabolism as well as the tolerability of the treatments with special emphasis on skin irritation and compliance were evaluated. Design An o pen, randomised, controlled, parallel-group trial of 12 months' durati on. Setting The Medical Clinic of Kalevankatu, Helsinki, Finland. Part icipants One hundred twenty postmenopausal women were treated with tra nsdermal oestradiol combined with dydrogesterone. In addition, 25 wome n without HRT served as a reference group for the bone mineral density measurements. Results Both treatment regimens were equally effective in alleviating climacteric symptoms, preserving bone mineral density a nd were equally safe. A trend towards heavier bleeding was detected in patients treated with the oestradiol delivering patch. A statisticall y nonsignificant decrease of total cholesterol and triglyceride concen trations but no change in high-density lipoprotein cholesterol concent ration was observed in both groups. The acceptability of the treatment was higher in the gel group (96.4%) than in the patch group (90.7%). Only two (3.3%) women using the oestradiol gel complained of skin irri tation whereas 28 patients (46.7%, P < 0.001) using the oestradiol del ivering patch reported this adverse effect. Conclusions Both the oestr adiol gel and the oestradiol delivering patch are equally effective in hormone replacement therapy but the gel preparation is less irritativ e to the skin.