Aromatase Inhibitors for Treatment of Uterine Leiomyomas
|Symptomatic or Large Uterine Fibroids||Drug: Letrozole (aromatase inhibitor)||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Aromatase Inhibitors for the Prevention of the Growth of Uterine Leiomyomas in Perimenopausal Women: A Pilot Study|
- 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. [ Time Frame: 2 months and 6 months following treatment ]
- Improvement in symptoms [ Time Frame: 2 and 6 months following treatment ]
- Need for a surgical intervention [ Time Frame: 2 and 6 months following treatment ]
- Improvement in the hemoglobin levels [ Time Frame: 2 and 6 months following treatment ]
- Development of side effects: hot flushes, nausea,vomiting, headache, thrombophlebitis [ Time Frame: 2 and 6 months following treatment ]
|Study Start Date:||March 2011|
|Study Completion Date:||May 2011|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
Experimental: aromatase inhibitors: Letrozole
All consenting patients will be started on Letrozole at a dose of 2.5 mg/day for 8 weeks.
Drug: Letrozole (aromatase inhibitor)
Letrozole at a dose of 2.5 mg/day for 8 weeks.
Other Name: Letrozole
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00945360
|American University of Beirut|
|Principal Investigator:||Anwar H Nassar, MD||American University of Beirut Medical Center|