GOSERELIN ACETATE PLUS IRON VS SHAM PLUS IRON FOR MANAGEMENT OF FIBRO

本研究是关于3个月10.8 mg醋酸戈舍林加铁与假加铁对绝经前子宫肌瘤所致缺铁性贫血妇女术前治疗的比较。本研究的主要目的是观察实现血红蛋白浓度增加的受试者百分比，接受血液学恢复的受试者百分比，以及随机化血红蛋白的平均增加。次要目的是比较治疗组之间缓解子宫肌瘤相关症状的差异，比较需要输血的受试者人数，比较有资格提供自体输血血液的受试者人数，比较肌瘤和子宫总体积的变化，比较醋酸戈舍林或假加铁的安全性和耐受性。

This study is of goserelin acetate (zoladex) 3-month 10.8 mg depot plus iron versus sham plus iron for the preoperative management of premenopausal women with iron deficiency anemia due to uterine fibroids. The primary objectives of this study are to see the percentage of subjects who achieve an increase in hemoglobin concentrations, the percentage of subjects who receive hematologic recovery, and the mean increase in hemoglobin from randomization. The secondary objectives are to compare the differences between treatment groups for the relief of symptoms associated with uterine fibroids, compare the number of subjects requiring blood transfusions, compare the number of subjects who are eligible to provide blood for autologous blood transfusion, compare the changes in fibroid and total uterine volume, and to compare the safety and tolerability of goserelin acetate or sham plus iron.