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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01280045
Other study ID # FMRPUSP-UROGIN-001
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date January 2011
Est. completion date January 2015

Study information

Verified date August 2020
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 5
Est. completion date January 2015
Est. primary completion date May 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 40 Years to 60 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- ACTIVE GYNECOLOGIC MALIGNANCY

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
VAGINAL HYSTERECTOMY
GOSERELINE ACETATE 10.8 MG FOR THREE MONTHS; ANASTROZOL ACETATE FOR THREE MONTHS

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo

References & Publications (1)

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 uter — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Operative Time Intra-operative time Intra-operative
Secondary Uterine Leiomyoma Volume Volume measured by ultrasound 3 Months After Treatment, During Surgery
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