Presurgical short term treatment of uterine fibroids with different doses of cetrorelix acetate: a double-blind, placebo-controlled multicenter study.

Objective: To assess the efficacy and safety of different dosing schedules of cetrorelix acetate as a short term treatment for 4 weeks prior to surgery in patients with uterine fibroids.

Study Design: Randomized, double-blind, placebo-controlled study. Patients were 109 premenopausal women, with at least one uterine fibroid, more than 4 cm in diameter. Groups 1-3 received placebo, 5 and 10 mg of cetrorelix on days 1, 8, 15 and 22, respectively group 4 received 10mg of cetrorelix on days 1 and 15. MRI scan was performed at screening and on day 29. The main outcome measure was the reduction of uterine volume on day 29 and response, defined as >30% size reduction.

Results: Mean (+/-S.D.) reduction of uterine volume on day 29 (MRI scan) was 5.1+/-32.1% with placebo, 15.6+/-20.2% with 4 x 5 mg, 15.4+/-34.6% with 4 x 10 mg and 0.6+/-30.6% with 2 x 10 mg cetrorelix. Significant response versus placebo (p<0.05) occurred in the 4 x 10 mg group (42.3% versus 11.1%)

Conclusions: Best objective response after 4 weeks of treatment was achieved after therapy with 4 x 10 mg of cetrorelix acetate. Short term presurgical treatment with the LHRH-antagonist cetrorelix is a flexible treatment protocol without any major side effects.