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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01280045

Enrollment

Registered

2011-01-20

Start date

2011-01-31

Completion date

2015-01-31

Last updated

2020-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

UTERINE LEIOMYOMA

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.

Interventions

PROCEDUREVAGINAL HYSTERECTOMY

GOSERELINE ACETATE 10.8 MG FOR THREE MONTHS; ANASTROZOL ACETATE FOR THREE MONTHS

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Intervention model description

We woudl be comparing aromatase inhibitors versus GnRH analogs

Eligibility

Sex/Gender

FEMALE

Age

40 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* ACTIVE GYNECOLOGIC MALIGNANCY

Design outcomes

Primary

Measure	Time frame	Description
Operative Time	Intra-operative	Intra-operative time

Secondary

Measure	Time frame	Description
Uterine Leiomyoma Volume	3 Months After Treatment, During Surgery	Volume measured by ultrasound

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026