Aromatase Inhibitors for Treatment of Uterine Leiomyomas

Study Overview
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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.

Official Title
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Aromatase Inhibitors for the Prevention of the Growth of Uterine Leiomyomas in Perimenopausal Women: A Pilot Study

Conditions
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Symptomatic or Large Uterine Fibroids

Intervention / Treatment
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* Drug: Letrozole (aromatase inhibitor)


Participation Criteria
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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: Women <50 years of age Postmenopausal women Women with impaired renal function Oral treatment with any type of estrogen or progesterone more recently than 1 month History of venous thromboembolism Any contraindication for Magnetic Resonance Imaging (MRI)

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: aromatase inhibitors: Letrozole<br>All consenting patients will be started on Letrozole at a dose of 2.5 mg/day for 8 weeks. | Drug: Letrozole (aromatase inhibitor)<br>* Letrozole at a dose of 2.5 mg/day for 8 weeks.<br>* Other names: Letrozole;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary end point of this study will be the baseline to end point percent difference in leiomyoma volume at 2 months and 6 months following treatment with Letrozole. |  | 2 months and 6 months following treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in symptoms |  | 2 and 6 months following treatment | 
| Need for a surgical intervention |  | 2 and 6 months following treatment | 
| Improvement in the hemoglobin levels |  | 2 and 6 months following treatment | 
| Development of side effects: hot flushes, nausea,vomiting, headache, thrombophlebitis |  | 2 and 6 months following treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Leiomyoma, perimenopause, aromatase inhibitor