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

Primary Purpose

UTERINE LEIOMYOMA

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
VAGINAL HYSTERECTOMY
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for UTERINE LEIOMYOMA

Eligibility Criteria

40 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • ACTIVE GYNECOLOGIC MALIGNANCY

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    AROMATASE INHIBITOR

    GNRH ANALOG

    Arm Description

    this would be compared before and after VAGINAL HYSTERECTOMY

    this would be compared before and after VAGINAL HYSTERECTOMY

    Outcomes

    Primary Outcome Measures

    Operative Time
    Intra-operative time

    Secondary Outcome Measures

    Uterine Leiomyoma Volume
    Volume measured by ultrasound

    Full Information

    First Posted
    January 10, 2011
    Last Updated
    August 12, 2020
    Sponsor
    University of Sao Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01280045
    Brief Title
    Influence of Aromatase Inhibitors and GnRH Analogs to Treat Uterine Leiomyoma by Vaginal Hysterectomy
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Terminated
    Why Stopped
    No grant was received then we stopped the recruitment
    Study Start Date
    January 2011 (undefined)
    Primary Completion Date
    May 2013 (Actual)
    Study Completion Date
    January 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Sao Paulo

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    UTERINE LEIOMYOMA

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    We woudl be comparing aromatase inhibitors versus GnRH analogs
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    5 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    AROMATASE INHIBITOR
    Arm Type
    Experimental
    Arm Description
    this would be compared before and after VAGINAL HYSTERECTOMY
    Arm Title
    GNRH ANALOG
    Arm Type
    Active Comparator
    Arm Description
    this would be compared before and after VAGINAL HYSTERECTOMY
    Intervention Type
    Procedure
    Intervention Name(s)
    VAGINAL HYSTERECTOMY
    Other Intervention Name(s)
    None declared
    Intervention Description
    GOSERELINE ACETATE 10.8 MG FOR THREE MONTHS; ANASTROZOL ACETATE FOR THREE MONTHS
    Primary Outcome Measure Information:
    Title
    Operative Time
    Description
    Intra-operative time
    Time Frame
    Intra-operative
    Secondary Outcome Measure Information:
    Title
    Uterine Leiomyoma Volume
    Description
    Volume measured by ultrasound
    Time Frame
    3 Months After Treatment, During Surgery

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: WOMEN OVER 40 YEARS, UTERINE VOLUME HIGHER THAN 300 ML, MINIMAL ANATOMIC CONDITIONS FOR VAGINAL SURGERY Exclusion Criteria: ACTIVE GYNECOLOGIC MALIGNANCY

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19135657
    Citation
    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. doi: 10.1016/j.fertnstert.2008.09.064. Epub 2009 Jan 9.
    Results Reference
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    Influence of Aromatase Inhibitors and GnRH Analogs to Treat Uterine Leiomyoma by Vaginal Hysterectomy

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