Aromatase Inhibitors for the Prevention of the Growth of Uterine Leiomyomas in Perimenopausal Women: A Pilot Study
50 Years
55 Years
Female
Symptomatic or Large Uterine Fibroids
Trial Information
Aromatase Inhibitors for the Prevention of the Growth of Uterine Leiomyomas in Perimenopausal Women: A Pilot Study
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.
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)
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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.
Outcome Time Frame:
2 months and 6 months following treatment
Safety Issue:
No
Principal Investigator
Anwar H Nassar, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
American University of Beirut Medical Center
Authority:
Lebanon: Institutional Review Board
Study ID:
OGY.AN.08
NCT ID:
NCT00945360
Start Date:
March 2011
Completion Date:
May 2011
Related Keywords:
- Symptomatic or Large Uterine Fibroids
- Leiomyoma
- perimenopause
- aromatase inhibitor
- Leiomyoma
- Myofibroma
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