GNRH AGONIST AND IRON VERSUS PLACEBO AND IRON IN THE ANEMIC PATIENT BEFORE SURGERY FOR LEIOMYOMAS - A RANDOMIZED CONTROLLED TRIAL

Objective: To determine the effectiveness of leuprolide acetate depot plus iron compared with iron alone in the preoperative treatment of an emia due to prolonged or excessive bleeding associated with uterine le iomyomas. Methods: This was a phase III, stratified, randomized, doubl e-blind, placebo-controlled, parallel-group, 12-week multicenter study . Enrolled patients had hemoglobin levels of 10.2 g/dL or less and/or hematocrit values of 30% or less. Patients were entered into one of tw o strata based on their pre-study hematocrit level: stratum A, hematoc rit less than or equal to 28%, and stratum B, hematocrit greater than 28%. Patients within each stratum were randomized to one of three trea tment arms: leuprolide acetate depot 7.5 mg, leuprolide acetate depot 3.75 mg, or placebo. All patients received iron orally. Response was d efined as a hemoglobin level of 12 g/dL or more and a hematocrit value of 36% or greater. Results: Three hundred nine patients were entered into the study, of whom 265 were evaluated. Using our response criteri a, a significantly greater number of patients in both leuprolide aceta te groups (combined strata) responded to therapy than did those in the placebo group: 74% in each leuprolide acetate group versus 46% in the placebo group (P < .001). Gonadotropin-releasing hormone agonist-trea ted patients had a significant reduction in uterine and myoma volume w hen compared with the placebo group (P < .01). Hot flashes and vaginit is were reported significantly more often (P < .001) in the leuprolide acetate-treated groups than in the placebo group. Conclusion: Both do sages of GnRH agonist plus iron were more effective than iron alone in treating the anemia. of patients with uterine leiomyomas, in reducing uterine-myoma volume, and in alleviating bleeding ana other leiomyoma -related symptoms.