Influence of Aromatase Inhibitors and GnRH Analogs to Treat Uterine Leiomyoma by Vaginal Hysterectomy

Not Applicable

Terminated

• Conditions: UTERINE LEIOMYOMA
• Interventions: Procedure: VAGINAL HYSTERECTOMY

• Registration Number: NCT01280045
• Lead Sponsor: University of Sao Paulo

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-10
• Study First Submitted QC: 2011-01-19
• Study First Posted: 2011-01-20
• Primary Completion: 2013-05
• Study Completion: 2015-01
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-12
• Last Update Posted: 2020-08-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 5

Inclusion Criteria

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

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Exclusion Criteria

• ACTIVE GYNECOLOGIC MALIGNANCY

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AROMATASE INHIBITOR	VAGINAL HYSTERECTOMY	this would be compared before and after VAGINAL HYSTERECTOMY
GNRH ANALOG	VAGINAL HYSTERECTOMY	this would be compared before and after VAGINAL HYSTERECTOMY

Primary Outcome Measures

Name	Time	Method
Operative Time	Intra-operative	Intra-operative time

Secondary Outcome Measures

Name	Time	Method
Uterine Leiomyoma Volume	3 Months After Treatment, During Surgery	Volume measured by ultrasound