Aromatase Inhibitors for Treatment of Uterine Leiomyomas
| Tracking Information | |||||
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| First Received Date ICMJE | July 23, 2009 | ||||
| Last Updated Date | July 12, 2012 | ||||
| Start Date ICMJE | March 2011 | ||||
| Primary Completion Date | May 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE |
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 3 months following treatment ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00945360 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Aromatase Inhibitors for Treatment of Uterine Leiomyomas | ||||
| Official Title ICMJE | Aromatase Inhibitors for the Prevention of the Growth of Uterine Leiomyomas in Perimenopausal Women: A Pilot Study | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Symptomatic or Large Uterine Fibroids | ||||
| Intervention ICMJE | Drug: Letrozole (aromatase inhibitor)
Letrozole at a dose of 2.5 mg/day for 8 weeks.
Other Name: Letrozole |
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| Study Arm (s) | Experimental: aromatase inhibitors: Letrozole
All consenting patients will be started on Letrozole at a dose of 2.5 mg/day for 8 weeks.
Intervention: Drug: Letrozole (aromatase inhibitor) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Withdrawn | ||||
| Enrollment ICMJE | 0 | ||||
| Completion Date | May 2011 | ||||
| Primary Completion Date | May 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | 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:
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| Gender | Female | ||||
| Ages | 50 Years to 55 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Lebanon | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00945360 | ||||
| Other Study ID Numbers ICMJE | OGY.AN.08 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Anwar Nassar, MD/Associate Professor, American University of Beirut Medical Center | ||||
| Study Sponsor ICMJE | American University of Beirut Medical Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | American University of Beirut Medical Center | ||||
| Verification Date | July 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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