Sustained-release estradiol implants and a levonorgestrel-releasing intrauterine device in hormone replacement therapy.
OBJECTIVE
Efficacy and acceptability of continuous combined parenteral hormone replacement consisting of subdermal estradiol delivery and intrauterine progestin delivery was studied.


METHODS
Thirty-six volunteer postmenopausal women seeking treatment for climacteric symptoms participated in this open, randomized study. The subjects received either one or three subdermal implants with a controlled daily release of estradiol in vitro. Progestin therapy was carried out with a levonorgestrel-releasing intrauterine device. Climacteric symptoms and serum concentrations of estrone, estradiol, follicle-stimulating hormone, and sex hormone-binding globulin were followed up for 1 year. The subjects kept daily records of bleeding.


RESULTS
Serum estradiol concentrations with the set of three implants were stable during the follow-up period; the range of mean serum estradiol concentrations was 45 to 57 pg/ml. Four women, all from the group with one implant, discontinued the study after 6 months because of the return of climacteric symptoms. In spite of different daily estradiol doses, the patterns of bleeding were similar in both groups. At the end of the follow-up year 72% of the women had had no bleeding or spotting in the previous 3 months.


CONCLUSIONS
Our results suggest that by combining subdermal and intrauterine steroid delivery systems postmenopausal hormone replacement therapy can be carried out successfully without daily effort and with minimal or no bleeding.
Helsinki City Maternity Hospital, Finland.
S P
SP
Suhonen
H O
HO
Allonen
P
P
Lähteenmäki
D004343:Drug Implants; D004958:Estradiol / Q000008:administration & dosage*; D015914:Estrogen Replacement Therapy / Q000379:methods*; D005260:Female; D006801:Humans; D007434:Intrauterine Devices; D016912:Levonorgestrel / Q000008:administration & dosage*; D008875:Middle Aged; D017698:Postmenopause; D014592:Uterine Hemorrhage
D004343:Drug Implants; D004958:Estradiol; D016912:Levonorgestrel