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

This study is currently recruiting participants.
Verified May 2012 by University of Sao Paulo
Sponsor:
Information provided by (Responsible Party):
LUIZ GUSTAVO OLIVEIRA BRITO, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01280045
First received: January 10, 2011
Last updated: May 29, 2012
Last verified: May 2012
History of Changes
  Purpose

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 Intervention Phase
UTERINE LEIOMYOMA
 Procedure: VAGINAL HYSTERECTOMY
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

MedlinePlus related topics: Hysterectomy
U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Operative Time [ Time Frame: 3 Months After Clinical Treatment, During Surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Uterine Leiomyoma Volume [ Time Frame: 3 Months After Treatment, During Surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: January 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AROMATASE INHIBITOR Procedure: VAGINAL HYSTERECTOMY
GOSERELINE ACETATE 10.8 MG FOR THREE MONTHS; ANASTROZOL ACETATE FOR THREE MONTHS
Other Name: None declared
Active Comparator: GNRH ANALOG Procedure: VAGINAL HYSTERECTOMY
GOSERELINE ACETATE 10.8 MG FOR THREE MONTHS; ANASTROZOL ACETATE FOR THREE MONTHS
Other Name: None declared

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.

  Eligibility

Ages Eligible for Study:   40 Years to 60 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01280045

Contacts
Contact: LUIZ GUSTAVO O BRITO, MD +551632356626 lbrito@usp.br

Locations
Brazil
Faculty of Medicine of Ribeirao Preto - Sao Paulo University Recruiting
Ribeirao Preto, Sao Paulo, Brazil, 14049900
Contact: FRANCISCO J CANDIDO DOS REIS, MD, PHD     +551636021000 ext 2585     fjcreis@fmrp.usp.br    
Principal Investigator: LUIZ GUSTAVO O BRITO, MD            
Sub-Investigator: PEDRO S MAGNANI, MD            
Sub-Investigator: HEITOR LEANDRO P RODRIGUES, MD            
Sub-Investigator: MARIA ANGELA C CARVALHO, MD            
Sub-Investigator: MAURICIO M SABINO-DE-FREITAS, MD, PHD            
Sponsors and Collaborators
University of Sao Paulo
Investigators
Study Chair: Francisco J Candido dos Reis, MD FMRP-USP
  More Information

Additional Information:
Summary about the proposed project  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: LUIZ GUSTAVO OLIVEIRA BRITO, Assistant Physician, MD, PhD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01280045     History of Changes
Other Study ID Numbers: FMRPUSP-UROGIN-001
Study First Received: January 10, 2011
Last Updated: May 29, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
 Neoplasms, Connective Tissue
Connective Tissue Diseases
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013