NCT00945360

Aromatase Inhibitors for Treatment of Uterine Leiomyomas

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

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: American University of Beirut Medical Center · Academic / Other
• Sex: Female
• Age: 50 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

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

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

• Symptomatic or Large Uterine Fibroids

Interventions

Type	Name	Description
DRUG	Letrozole (aromatase inhibitor)	Letrozole at a dose of 2.5 mg/day for 8 weeks.

Timeline

• Start date: 2011-03-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2009-07-24
• Last updated: 2012-07-13

Locations

1 site across 1 country: Lebanon