TRANSDERMAL ESTRADIOL GEL IN THE TREATMENT OF THE CLIMACTERIUM - A COMPARISON WITH ORAL-THERAPY

Objective To compare two doses of a transdermal oestradiol gel (Divige l(R)/Sandrena(R)) plus oral sequential medroxyprogesterone acetate (MP A) with oral oestradiol valerate plus oral sequential MPA (Divina(R)/D ilena(R)). Design Two-year, randomised, open-label, comparative study. Setting Menopausal outpatient clinic in Helsinki. Subjects Postmenopa usal women with climacteric complaints or already using HRT. Intervent ions (1) One gram gel containing 1 mg oestradiol for 3 months plus 20 mg oral MPA during the last 14 days; (2) 2 g gel containing 2 mg oestr adiol for 21 days plus 10 mg oral MPA during the last 14 days; (3) 2 m g oestradiol valerate tablets for 3 weeks plus 10 mg oral MPA during t he last 10 days. In all groups, each treatment period was followed by a 7-day medication-free interval. Main outcome measures Climacteric co mplaints, bleeding control, bone mineral density, biomarkers of bone m etabolism, lipid profile, tolerability and safety.Results With each pr eparation, climacteric complaints were significantly reduced and good bleeding control was obtained. In addition, maintenance of bone minera l density as well as a reduction of bone turnover was achieved in all groups. Lipid parameters showed no unfavourable changes. Continuation rates were similar in all groups with overall 74% of patients completi ng the first year, whereas 94% of patients who elected to continue com pleted the second year. Tolerability of the gel was good: only 1.7% of patients discontinued treatment due to skin irritation. Conclusions T ransdermal oestradiol gel and oral oestradiol valerate tablets, used i n combination with oral sequential MPA, are effective regimens of HRT in postmenopausal women. Transdermal oestradiol gel is an efficient, w ell-tolerated form of HRT.