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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 : Unknown
Verified May 2012 by LUIZ GUSTAVO OLIVEIRA BRITO, University of Sao Paulo.
Recruitment status was:  Recruiting
First Posted : January 20, 2011
Last Update Posted : May 31, 2012
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 Phase 3

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  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Estimated Primary Completion Date : May 2013
Estimated Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Operative Time [ Time Frame: 3 Months After Clinical Treatment, During Surgery ]

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


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:
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
First Posted: January 20, 2011    Key Record Dates
Last Update Posted: May 31, 2012
Last Verified: May 2012

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
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs