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临床试验/NCT01280045
NCT01280045终止不适用

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

University of Sao Paulo0 个研究点目标入组 5 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
5
主要终点
Operative Time

研究概览

简要总结

The investigators aimed to assess if use of aromatase inhibitors could decrease volume of uterine leiomyoma and cause same percentage of adverse effects during its use compared to GnRH analogs.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • WOMEN OVER 40 YEARS, UTERINE VOLUME HIGHER THAN 300 ML, MINIMAL ANATOMIC CONDITIONS FOR VAGINAL SURGERY

排除标准

  • ACTIVE GYNECOLOGIC MALIGNANCY

结局指标

主要结局

Operative Time

时间窗: Intra-operative

Intra-operative time

次要结局

  • Uterine Leiomyoma Volume(3 Months After Treatment, During Surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

LUIZ GUSTAVO OLIVEIRA BRITO

Assistant Physician, MD, PhD

University of Sao Paulo

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