Aromatase Inhibitors for Treatment of Uterine Leiomyomas

• Status: Withdrawn
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: American University of Beirut Medical Center
• Treatments: Aromatase Inhibitors; Letrozole

Criteria

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)