Influence of the Aromatase Inhibitor Anastrozole and GnRH Analog Goserelin Acetate as Preoperative Treatment of Vaginal Surgical Treatment of Uterine Leiomyoma: Analysis of Intra and Immediate/Late Postoperative Patterns
Uterine leiomyoma is the most prevalent benign gynecologic tumor in women. Standard
treatment is surgical (hysterectomy or myomectomy), and depends of many variables. If these
tumors are large, preoperative assessment with clinical treatment may be useful in order to
decrease its volume, improve hematologic patterns and modify surgical approach (vaginal or
abdominal). It is well know that GnRH analogs can cause these goals; however, aromatase
inhibitors are new promising drugs which are being used for reducing uterine leiomyoma's
volume and few observational studies have shown this fact. The investigators are aiming to
compare both treatments in a randomized controlled trial and see if it both treatments are
similar or not in decreasing uterine leiomyoma's volume, influencing operative time, blood
loss during surgery.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
Operative Time
3 Months After Clinical Treatment, During Surgery
Yes
Francisco J Candido dos Reis, MD
Study Chair
FMRP-USP
Brazil: National Committee of Ethics in Research
FMRPUSP-UROGIN-001
NCT01280045
January 2011
January 2015
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