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 cetrorefix on days 1, 8, 15 and 22, respectively group 4 received 10 mg of cetrorefix 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. (C) 2006 Elsevier Ireland Ltd. All rights reserved.