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.


METHODS
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.
Engel
Jörg B
JB
Frauenklinik der Julius Maximilians-Universität Würzburg, Josef-Schneider-Str. 4, 97070 Würzburg, Germany. joergbengel@hotmail.com
Audebert
Alain
A
Frydman
René
R
Zivny
Jaroslav
J
Diedrich
Klaus
K
D000328:Adult; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D007987:Gonadotropin-Releasing Hormone / Q000008:administration & dosage / Q000031:analogs & derivatives*; D006727:Hormone Antagonists / Q000008:administration & dosage*; D006801:Humans; D007044:Hysterectomy; D007279:Injections, Subcutaneous; D018231:Leiomyomatosis / Q000188:drug therapy* / Q000601:surgery; D008875:Middle Aged; D009929:Organ Size / Q000187:drug effects; D011300:Preoperative Care; D016896:Treatment Outcome; D014594:Uterine Neoplasms / Q000188:drug therapy* / Q000601:surgery; D014599:Uterus / Q000187:drug effects / Q000473:pathology
D006727:Hormone Antagonists; D007987:Gonadotropin-Releasing Hormone; C062876:cetrorelix