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Aromatase Inhibitors for Treatment of Uterine Leiomyomas

NCT ID: NCT00945360

Last Updated: 2012-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2011-05-31

Brief Summary

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Fibroids are benign tumors that might results in bleeding. Surgery is their definitive treatment. Some medical therapies have been tried for women who wish to preserve their uterus. Recent reports have demonstrated a role for a new category of drugs called aromatase inhibitor (such as Femara) in the treatment of fibroids. This study is conducted to assess the effect of Femara (letrozole) on the size of fibroids in women around menopause.

Detailed Description

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Fibroids (leiomyomas) are benign tumors that originate in the musculature of the uterus. They are the most common cause for removal of the uterus in women. Surgery is the final definitive treatment of fibroids. However, surgery is relatively risky. Hence, a few medical therapies have been tried for women who wish to preserve their uterus. However, most of those therapies have side effects that prohibit their routine use. Recent reports have demonstrated a role for a new category of drugs called aromatase inhibitor ( such as Femara) in the treatment of fibroids. To the best of our knowledge, this drug has not been studied yet in the management of fibroid of the uterus apart from one case report.

The objective of the current study is to assess the effect of aromatase inhibitors, specifically Femara (letrozole) on the size of fibroids in women around menopause. We are hoping that by decreasing their size, we could avoid having patients undergo surgery. The data generated is invaluable in that sense.

Conditions

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Symptomatic or Large Uterine Fibroids

Keywords

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Leiomyoma perimenopause aromatase inhibitor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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aromatase inhibitors: Letrozole

All consenting patients will be started on Letrozole at a dose of 2.5 mg/day for 8 weeks.

Group Type EXPERIMENTAL

Letrozole (aromatase inhibitor)

Intervention Type DRUG

Letrozole at a dose of 2.5 mg/day for 8 weeks.

Interventions

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Letrozole (aromatase inhibitor)

Letrozole at a dose of 2.5 mg/day for 8 weeks.

Intervention Type DRUG

Other Intervention Names

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Letrozole

Eligibility Criteria

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Inclusion Criteria

1\. Perimenopausal women (≥ 50 years) with symptomatic uterine leiomyomas (menometrorrhagia, pressure symptoms, urinary retention, pelvic pain) or those with large leiomyomas ≥ 7 cms

Exclusion Criteria

1. Women \<50 years of age
2. Postmenopausal women
3. Women with impaired renal function
4. Oral treatment with any type of estrogen or progesterone more recently than 1 month
5. History of venous thromboembolism
6. Any contraindication for Magnetic Resonance Imaging (MRI)
Minimum Eligible Age

50 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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American University of Beirut Medical Center

OTHER

Sponsor Role lead

Responsible Party

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American University of Beirut Medical Center

Principal Investigators

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Anwar H Nassar, MD

Role: PRINCIPAL_INVESTIGATOR

American University of Beirut Medical Center

Locations

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American University of Beirut

Beirut, , Lebanon

Site Status

Countries

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Lebanon

Other Identifiers

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OGY.AN.08

Identifier Type: -

Identifier Source: org_study_id