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

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ClinicalTrials.gov Identifier: NCT01280045
Recruitment Status : Terminated (No grant was received then we stopped the recruitment)
First Posted : January 20, 2011
Last Update Posted : August 13, 2020
Sponsor:
Information provided by (Responsible Party):
LUIZ GUSTAVO OLIVEIRA BRITO, 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.

Condition or disease Intervention/treatment Phase
UTERINE LEIOMYOMA Procedure: VAGINAL HYSTERECTOMY Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: We woudl be comparing aromatase inhibitors versus GnRH analogs
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2011
Actual Primary Completion Date : May 2013
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

Arm Intervention/treatment
Experimental: AROMATASE INHIBITOR
this would be compared before and after VAGINAL HYSTERECTOMY
Procedure: VAGINAL HYSTERECTOMY
GOSERELINE ACETATE 10.8 MG FOR THREE MONTHS; ANASTROZOL ACETATE FOR THREE MONTHS
Other Name: None declared

Active Comparator: GNRH ANALOG
this would be compared before and after VAGINAL HYSTERECTOMY
Procedure: VAGINAL HYSTERECTOMY
GOSERELINE ACETATE 10.8 MG FOR THREE MONTHS; ANASTROZOL ACETATE FOR THREE MONTHS
Other Name: None declared




Primary Outcome Measures :
  1. Operative Time [ Time Frame: Intra-operative ]
    Intra-operative time


Secondary Outcome Measures :
  1. Uterine Leiomyoma Volume [ Time Frame: 3 Months After Treatment, During Surgery ]
    Volume measured by ultrasound



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • ACTIVE GYNECOLOGIC MALIGNANCY
Publications of Results:
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Responsible Party: LUIZ GUSTAVO OLIVEIRA BRITO, Assistant Physician, MD, PhD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01280045    
Other Study ID Numbers: FMRPUSP-UROGIN-001
First Posted: January 20, 2011    Key Record Dates
Last Update Posted: August 13, 2020
Last Verified: August 2020
Additional relevant MeSH terms:
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Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases