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

This study is currently recruiting participants. (see Contacts and Locations)
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

January 10, 2011
May 29, 2012
January 2011
May 2013   (final data collection date for primary outcome measure)
Operative Time [ Time Frame: 3 Months After Clinical Treatment, During Surgery ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01280045 on ClinicalTrials.gov Archive Site
Uterine Leiomyoma Volume [ Time Frame: 3 Months After Treatment, During Surgery ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Influence of Aromatase Inhibitors and GnRH Analogs to Treat Uterine Leiomyoma by Vaginal Hysterectomy
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
UTERINE LEIOMYOMA
Procedure: VAGINAL HYSTERECTOMY
GOSERELINE ACETATE 10.8 MG FOR THREE MONTHS; ANASTROZOL ACETATE FOR THREE MONTHS
Other Name: None declared
  • Experimental: AROMATASE INHIBITOR
    Intervention: Procedure: VAGINAL HYSTERECTOMY
  • Active Comparator: GNRH ANALOG
    Intervention: Procedure: VAGINAL HYSTERECTOMY
Parsanezhad ME, Azmoon M, Alborzi S, Rajaeefard A, Zarei A, Kazerooni T, Frank V, Schmidt EH. A randomized, controlled clinical trial comparing the effects of aromatase inhibitor (letrozole) and gonadotropin-releasing hormone agonist (triptorelin) on uterine leiomyoma volume and hormonal status. Fertil Steril. 2010 Jan;93(1):192-8. Epub 2009 Jan 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
January 2015
May 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • ACTIVE GYNECOLOGIC MALIGNANCY
Female
40 Years to 60 Years
Yes
Contact: LUIZ GUSTAVO O BRITO, MD +551632356626 lbrito@usp.br
Brazil
 
NCT01280045
FMRPUSP-UROGIN-001
No
LUIZ GUSTAVO OLIVEIRA BRITO, University of Sao Paulo
University of Sao Paulo
Not Provided
Study Chair: Francisco J Candido dos Reis, MD FMRP-USP
University of Sao Paulo
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP