Aromatase Inhibitors for Treatment of Uterine Leiomyomas

Symptomatic or Large Uterine Fibroids Clinical Trial

Official title:

Aromatase Inhibitors for the Prevention of the Growth of Uterine Leiomyomas in Perimenopausal Women: A Pilot Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00945360
• Other study ID #: OGY.AN.08
• Status: Withdrawn
• Phase: Phase 1
• First received: July 23, 2009
• Last updated: July 12, 2012
• Start date: March 2011
• Est. completion date: May 2011

Study information

• Verified date: July 2009
• Source: American University of Beirut Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Lebanon: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 55 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leiomyoma
• Symptomatic or Large Uterine Fibroids

Intervention

Drug:
• Letrozole (aromatase inhibitor)
Letrozole at a dose of 2.5 mg/day for 8 weeks.

Locations

Country	Name	City	State
Lebanon	American University of Beirut	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
American University of Beirut Medical Center

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Improvement in symptoms		2 and 6 months following treatment	Yes
Secondary	Need for a surgical intervention		2 and 6 months following treatment	Yes
Secondary	Improvement in the hemoglobin levels		2 and 6 months following treatment	Yes
Secondary	Development of side effects: hot flushes, nausea,vomiting, headache, thrombophlebitis		2 and 6 months following treatment	Yes