Inability to recruit patients
Aromatase Inhibitors for the Prevention of the Growth of Uterine Leiomyomas in Perimenopausal Women: A Pilot Study
Sponsor study identifier
interventional
0
1 country
1
Study Start
March 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2011
Actual (reported)Study Completion
May 2011
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 23, 2009
Actual (reported)July 24, 2009
Actual (reported)March 2011
Date type not reportedThis date has not been verified as actual or estimated.
May 2011
Actual (reported)May 2011
Actual (reported)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
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
All consenting patients will be started on Letrozole at a dose of 2.5 mg/day for 8 weeks.
Letrozole at a dose of 2.5 mg/day for 8 weeks.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
American University of Beirut
Beirut, Lebanon
Anwar H Nassar, MD
American University of Beirut Medical Center
0 participants (actual enrollment reported by the registry).
First Submitted
July 23, 2009
First Posted
July 24, 2009
Study Start
March 2011
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
May 2011
Actual (reported)Study Completion
May 2011
Actual (reported)Last Updated
July 13, 2012
Record last verified: 2009-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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