Aromatase Inhibitors for Treatment of Uterine Leiomyomas

Phase 1

Withdrawn

• Conditions: Symptomatic or Large Uterine Fibroids
• Interventions: Drug: Letrozole (aromatase inhibitor)

• Registration Number: NCT00945360
• Lead Sponsor: American University of Beirut Medical Center

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.

Study Timeline

• Status Verified: 2009-07
• Study First Submitted: 2009-07-23
• Study First Submitted QC: 2009-07-23
• Study First Posted: 2009-07-24
• Study Start: 2011-03
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Last Update Submitted: 2012-07-12
• Last Update Posted: 2012-07-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
aromatase inhibitors: Letrozole	Letrozole (aromatase inhibitor)	All consenting patients will be started on Letrozole at a dose of 2.5 mg/day for 8 weeks.

Primary Outcome Measures

Name	Time	Method
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.	2 months and 6 months following treatment

Secondary Outcome Measures

Name	Time	Method
Improvement in symptoms	2 and 6 months following treatment
Need for a surgical intervention	2 and 6 months following treatment
Improvement in the hemoglobin levels	2 and 6 months following treatment
Development of side effects: hot flushes, nausea,vomiting, headache, thrombophlebitis	2 and 6 months following treatment

Trial Locations

Locations (1)

American University of Beirut; 🇱🇧 Beirut, Lebanon