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

August 12, 2020 updated by: LUIZ GUSTAVO OLIVEIRA BRITO, University of Sao Paulo

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • ACTIVE GYNECOLOGIC MALIGNANCY

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • None declared

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

January 10, 2011

First Submitted That Met QC Criteria

January 19, 2011

First Posted (Estimate)

January 20, 2011

Study Record Updates

Last Update Posted (Actual)

August 13, 2020

Last Update Submitted That Met QC Criteria

August 12, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMRPUSP-UROGIN-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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