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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


Phase 3
40 Years
60 Years
Open (Enrolling)
Female
UTERINE LEIOMYOMA

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Trial Information

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


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.


Inclusion Criteria:



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

Exclusion Criteria:

- ACTIVE GYNECOLOGIC MALIGNANCY

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Operative Time

Outcome Time Frame:

3 Months After Clinical Treatment, During Surgery

Safety Issue:

Yes

Principal Investigator

Francisco J Candido dos Reis, MD

Investigator Role:

Study Chair

Investigator Affiliation:

FMRP-USP

Authority:

Brazil: National Committee of Ethics in Research

Study ID:

FMRPUSP-UROGIN-001

NCT ID:

NCT01280045

Start Date:

January 2011

Completion Date:

January 2015

Related Keywords:

  • Uterine Leiomyoma
  • Leiomyoma
  • Myofibroma

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