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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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UTERINE LEIOMYOMA

Intervention / Treatment
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* Procedure: VAGINAL HYSTERECTOMY


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: WOMEN OVER 40 YEARS, UTERINE VOLUME HIGHER THAN 300 ML, MINIMAL ANATOMIC CONDITIONS FOR VAGINAL SURGERY Exclusion Criteria: ACTIVE GYNECOLOGIC MALIGNANCY

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: We woudl be comparing aromatase inhibitors versus GnRH analogs
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AROMATASE INHIBITOR<br>this would be compared before and after VAGINAL HYSTERECTOMY | Procedure: VAGINAL HYSTERECTOMY<br>* GOSERELINE ACETATE 10.8 MG FOR THREE MONTHS; ANASTROZOL ACETATE FOR THREE MONTHS<br>* Other names: None declared;|
| Active Comparator: GNRH ANALOG<br>this would be compared before and after VAGINAL HYSTERECTOMY | Procedure: VAGINAL HYSTERECTOMY<br>* GOSERELINE ACETATE 10.8 MG FOR THREE MONTHS; ANASTROZOL ACETATE FOR THREE MONTHS<br>* Other names: None declared;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative Time | Intra-operative time | Intra-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uterine Leiomyoma Volume | Volume measured by ultrasound | 3 Months After Treatment, During Surgery |