Aromatase Inhibitors for Treatment of Uterine Leiomyomas

This study has been withdrawn prior to enrollment.
(Inability to recruit patients)
Sponsor:
Information provided by:
American University of Beirut Medical Center
ClinicalTrials.gov Identifier:
NCT00945360
First received: July 23, 2009
Last updated: July 12, 2012
Last verified: July 2009
  Purpose

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.


Condition Intervention Phase
Symptomatic or Large Uterine Fibroids
Drug: Letrozole (aromatase inhibitor)
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Aromatase Inhibitors for the Prevention of the Growth of Uterine Leiomyomas in Perimenopausal Women: A Pilot Study

Resource links provided by NLM:


Further study details as provided by American University of Beirut Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in symptoms [ Time Frame: 2 and 6 months following treatment ] [ Designated as safety issue: Yes ]
  • Need for a surgical intervention [ Time Frame: 2 and 6 months following treatment ] [ Designated as safety issue: Yes ]
  • Improvement in the hemoglobin levels [ Time Frame: 2 and 6 months following treatment ] [ Designated as safety issue: Yes ]
  • Development of side effects: hot flushes, nausea,vomiting, headache, thrombophlebitis [ Time Frame: 2 and 6 months following treatment ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: March 2011
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   50 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00945360

Locations
Lebanon
American University of Beirut
Beirut, Lebanon
Sponsors and Collaborators
American University of Beirut Medical Center
Investigators
Principal Investigator: Anwar H Nassar, MD American University of Beirut Medical Center
  More Information

No publications provided

Responsible Party: Anwar Nassar, MD/Associate Professor, American University of Beirut Medical Center
ClinicalTrials.gov Identifier: NCT00945360     History of Changes
Other Study ID Numbers: OGY.AN.08
Study First Received: July 23, 2009
Last Updated: July 12, 2012
Health Authority: Lebanon: Institutional Review Board

Keywords provided by American University of Beirut Medical Center:
Leiomyoma
perimenopause
aromatase inhibitor

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Letrozole
Aromatase Inhibitors
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 15, 2014