Clinical trial NCT00945360: Aromatase Inhibitors for Treatment of Uterine Leiomyomas
Official title: Aromatase Inhibitors for the Prevention of the Growth of Uterine Leiomyomas in Perimenopausal Women: A Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Symptomatic or Large Uterine Fibroids
Keywords: Leiomyoma
perimenopause
aromatase inhibitor
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
First posted: 2009-07-24
Enrollment: 0
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility 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)

Primary outcomes:
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.
timeFrame: 2 months and 6 months following treatment
Secondary outcomes:
measure: Improvement in symptoms
timeFrame: 2 and 6 months following treatment
measure: Need for a surgical intervention
timeFrame: 2 and 6 months following treatment
measure: Improvement in the hemoglobin levels
timeFrame: 2 and 6 months following treatment
measure: Development of side effects: hot flushes, nausea,vomiting, headache, thrombophlebitis
timeFrame: 2 and 6 months following treatment
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: American University of Beirut
Study officials:
affiliation: American University of Beirut Medical Center
name: Anwar H Nassar, MD
role: PRINCIPAL_INVESTIGATOR
References: