Abstract
The present study was undertaken to evaluate the efficacy of monthly subcutaneous administration of a long-acting gonadotropin-releasing hormone agonist (GnRHa, leuprolide acetate, TAP-144-SR) in the treatment of uterine leiomyomata. Twenty patients, aged 41 to 53, with leiomyomata were treated with TAP-144-SR for 6 months. All patients experienced amenorrhea 8 weeks after the onset of treatment, whereas the resumption of menstruation occurred in 18 patients after the cessation of treatment. There was a significant increase in hemoglobin concentration after 20 weeks of treatment. This increase reflected the diminution of menstrual blood loss. After the initial transient stimulation, serum levels of luteinizing hormone (LH) were suppressed during therapy with TAP-144-SR. The serum levels of follicle-stimulating hormone (FSH) dropped within a week, remaining at a relatively steady level. Serum levels of E_2 increased until 2 weeks after the onset of treatment and abruptly declined to menopausal levels (<30pg/ml). A statistically significant reduction in uterine volume was observed 8 weeks after the onset of treatment. After cessation of therapy, however, mean uterine volume increased to pretreatment values. There was a significant correlation (p<0.001) between the percentage of uterine volume reduction and the degree of hypoestrogenism achieved during the therapy. In 2 patients who reached menopause after treatment, LH, FSH and E_2 serum levels remained in the castrate range, resulting in no further significant change in uterine volume. In conclusion, monthly subcutaneous administration of TAP-144-SR was clinically effective in significantly decreasing uterine volume and increasing hemoglobin concentration in patients with leiomyomata.
