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

$11,180M01FY2000RRNIH

Tulane University Of Louisiana, New Orleans LA

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Abstract

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.

View original record on NIH RePORTER →