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

University of Sao Paulo

Status: Terminated

Conditions: UTERINE LEIOMYOMA

Treatments: Procedure: VAGINAL HYSTERECTOMY

Study type: Interventional

Funder types: Other

Identifiers

NCT01280045

FMRPUSP-UROGIN-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: Female

Ages: 40 to 60 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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5 participants in 2 patient groups

AROMATASE INHIBITOR

Experimental group

Description:

this would be compared before and after VAGINAL HYSTERECTOMY

Treatment:

Procedure: VAGINAL HYSTERECTOMY

GNRH ANALOG

Active Comparator group

Description:

this would be compared before and after VAGINAL HYSTERECTOMY

Treatment:

Procedure: VAGINAL HYSTERECTOMY