Efficacy of a low-dose leuprolide acetate depot in the treatment of uterine leiomyomata in Japanese women.
OBJECTIVE
To compare the efficacy of two different doses, 1.88 mg and 3.75 mg, of a monthly depot injection of a gonadotropin-releasing hormone agonist (GnRH-a) in the treatment of uterine leiomyomata.


METHODS
A prospective randomized study.


METHODS
Hospital department of gynecology and obstetrics.


METHODS
Forty-one premenopausal Japanese women, 25 to 53 years of age, with uterine leiomyomata.


METHODS
Depot type of GnRH-a, leuprolide acetate (LA) 1.88 mg or 3.75 mg was administered subcutaneously every 4 weeks for 24 weeks.


METHODS
Efficacy of treatment was assessed in terms of uterine volume, serum levels of estradiol (E2), luteinizing hormone (LH), follicle-stimulating hormone (FSH), and adverse symptoms during treatment.


RESULTS
In both groups, a significant reduction in uterine volume, 52% in 1.88 mg group and 47% in 3.75 mg group, was obtained at week 24, with near maximal reduction (41%, 45%) apparent by 12 weeks. No significant difference was observed between the groups in percent uterine volume reduction at each treatment week. Both groups showed significant and equal suppression of serum levels of E2, LH, and FSH. In addition, the incidence of adverse symptoms was not significantly different between the two groups.


CONCLUSIONS
Monthly injection of 1.88 mg or 3.75 mg LA depot has equivalent treatment efficacy in reducing uterine volume. Twelve weeks of treatment is enough to obtain near maximal reduction.
Watanabe
Y
Y
Department of Gynecology and Obstetrics, Faculty of Medicine, Kyushu University, Fukuoka, Japan.
Nakamura
G
G
Matsuguchi
H
H
Nozaki
M
M
Sano
M
M
Nakano
H
H
D000328:Adult; D003692:Delayed-Action Preparations; D004305:Dose-Response Relationship, Drug; D004958:Estradiol / Q000097:blood; D005260:Female; D005640:Follicle Stimulating Hormone / Q000097:blood; D007987:Gonadotropin-Releasing Hormone / Q000494:pharmacology; D006801:Humans; D007564:Japan / Q000453:epidemiology; D007889:Leiomyoma / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000453:epidemiology; D016729:Leuprolide / Q000009:adverse effects / Q000592:standards* / Q000627:therapeutic use; D007986:Luteinizing Hormone / Q000097:blood; D008875:Middle Aged; D011446:Prospective Studies; D014463:Ultrasonography; D014594:Uterine Neoplasms / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000453:epidemiology; D014599:Uterus / Q000000981:diagnostic imaging / Q000502:physiology
D003692:Delayed-Action Preparations; D007987:Gonadotropin-Releasing Hormone; D004958:Estradiol; D007986:Luteinizing Hormone; D005640:Follicle Stimulating Hormone; D016729:Leuprolide