Effects of transdermal oestrogen therapy in postmenopausal women: a comparative study of an oestradiol gel and an oestradiol delivering patch.
OBJECTIVE
To compare the efficacy, safety and tolerability of an oestradiol gel (1.0 mg of oestradiol daily, Divigel/Sandrena) with those of an oestradiol delivering patch (delivering 50 micrograms oestradiol/24 h, Estraderm TTS) in hormone replacement therapy of postmenopausal women. Dydrogesterone tablets (Terolut), 10 mg daily for the first 12 days of every month, were used as the progestogen component of the therapy.


METHODS
The effect of treatment on clinical symptoms 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.


METHODS
An open, randomised, controlled, parallel-group trial of 12 months' duration.


METHODS
The Medical Clinic of Kalevankatu, Helsinki, Finland.


METHODS
One hundred twenty postmenopausal women were treated with transdermal oestradiol combined with dydrogesterone. In addition, 25 women 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 and were equally safe. A trend towards heavier bleeding was detected in patients treated with the oestradiol delivering patch. A statistically nonsignificant decrease of total cholesterol and triglyceride concentrations but no change in high-density lipoprotein cholesterol concentration 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 irritation whereas 28 patients (46.7%, P < 0.001) using the oestradiol delivering patch reported this adverse effect.


CONCLUSIONS
Both the oestradiol gel and the oestradiol delivering patch are equally effective in hormone replacement therapy but the gel preparation is less irritative to the skin.
Hirvonen
E
E
Department of Obstetrics and Gynaecology, Helsinki University Central Hospital, Finland.
Cacciatore
B
B
Wahlström
T
T
Rita
H
H
Wilén-Rosenqvist
G
G
D000279:Administration, Cutaneous; D000368:Aged; D015519:Bone Density; D004359:Drug Therapy, Combination; D004394:Dydrogesterone / Q000008:administration & dosage; D004717:Endometrium / Q000033:anatomy & histology; D004958:Estradiol / Q000008:administration & dosage* / Q000097:blood; D015914:Estrogen Replacement Therapy / Q000379:methods*; D004970:Estrone / Q000097:blood; D005260:Female; D005782:Gels; D019584:Hot Flashes; D006801:Humans; D008875:Middle Aged; D017060:Patient Satisfaction; D045167:Progesterone Congeners / Q000008:administration & dosage*; D014592:Uterine Hemorrhage
D005782:Gels; D045167:Progesterone Congeners; D004970:Estrone; D004958:Estradiol; D004394:Dydrogesterone