Aromatase Inhibitors for Treatment of Uterine Leiomyomas

American University of Beirut Medical Center

Status and phase: Withdrawn; Phase 1

Conditions: Symptomatic or Large Uterine Fibroids

Treatments: Drug: Letrozole (aromatase inhibitor)

Study type: Interventional

Funder types: Other

Identifiers

NCT00945360

OGY.AN.08

Details and patient eligibility

About

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.

Full description

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.

Sex: Female

Ages: 50 to 55 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

aromatase inhibitors: Letrozole

Experimental group

Description:

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

Treatment:

Drug: Letrozole (aromatase inhibitor)