Eighteen premenopausal women with symptomatic leiomyomata uteri were enrolled in a stratified, randomized, double-blind, placebo-controlled study evaluating the efficacy of leuprolide acetate (LA) depot treatment before myomectomy. Stratification was based on pretreatment uterine volume (less than 600 cm3 versus greater than or equal to 600 cm3). Nine women received intramuscular (IM) depot LA 3.75 mg every 4 weeks for 12 weeks (group A); nine women received IM placebo with the same injection schedule (group B). All women underwent myomectomy within 4 weeks of their last injection. Mean total intraoperative blood loss was 213 +/- 44 mL (mean +/- standard error of the mean [SEM]) in group A and 302 +/- 43 mL in group B. When data from patients with large uteri (pretreatment uterine volumes of 600 cm3 or greater) were analyzed, mean total blood loss was 189 +/- 44 mL in group A and 390 +/- 20 mL in group B. These data suggest that leuprolide depot treatment before myomectomy may decrease intraoperative blood loss in women with large leiomyomata uteri.