The efficacy of the
luteinizing hormone-releasing hormone antagonist
Cetrorelix (SB-75) in the medical management of uterine
leiomyomas (
fibromas) was evaluated.
Cetrorelix was administered to 18 pre-menopausal women with
myomas with a mean age of 33.3 years, who had been candidates for
hysterectomy. The initial dose of
Cetrorelix was 5 mg twice daily s.c. for the first 2 days and thereafter 0.8 mg was given twice daily s.c. for at least 3 months. The mean duration of the treatment was 4.4 months. Before the
therapy with
Cetrorelix, the mean uterine volume, measured by ultrasonography, was 395.4 +/- 69.2 ml (range 89-1166). Sixteen patients showed a progressive reduction in uterine volume from 410.4 +/- 77.1 to a mean of 230.8 +/- 52.6 ml at 3 months. All patients became amenorrhoeic and had hot flushes.
After treatment with
Cetrorelix, a surgical
myomectomy was performed in 12 women. One of the patients subjected to
myomectomy after
therapy with
Cetrorelix became pregnant. These patients have been followed for up to 25 months and only in one case has the uterine volume increased after
therapy. Three patients had good responses to
therapy with
Cetrorelix and it was decided to follow them only by observation. One patient became pregnant 2 months later. In the other patient, the uterine volume remained unchanged for the duration of the follow-up of 2 years and the third patient showed an increase after 21 months. In three patients, it was necessary to perform total
hysterectomy. In 14 patients, serum concentrations of
luteinizing hormone,
follicle stimulating hormone and
oestradiol decreased after the administration of the first dose of
Cetrorelix and continued at subnormal values throughout
therapy. In 15 patients who were not subjected to total
hysterectomy, menstrual function returned at 1 month after
cessation of treatment. Overall results support the use of
Cetrorelix for the management of uterine
leiomyomas.