Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-26 @ 12:44 AM
Study NCT ID:
NCT00945360
Status:
WITHDRAWN
Last Update Posted:
2012-07-13
First Post:
2009-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aromatase Inhibitors for Treatment of Uterine Leiomyomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007889', 'term': 'Leiomyoma'}], 'ancestors': [{'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077289', 'term': 'Letrozole'}, {'id': 'D047072', 'term': 'Aromatase Inhibitors'}], 'ancestors': [{'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D065088', 'term': 'Steroid Synthesis Inhibitors'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D004965', 'term': 'Estrogen Antagonists'}, {'id': 'D006727', 'term': 'Hormone Antagonists'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Inability to recruit patients', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-12', 'studyFirstSubmitDate': '2009-07-23', 'studyFirstSubmitQcDate': '2009-07-23', 'lastUpdatePostDateStruct': {'date': '2012-07-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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.', 'timeFrame': '2 months and 6 months following treatment'}], 'secondaryOutcomes': [{'measure': 'Improvement in symptoms', 'timeFrame': '2 and 6 months following treatment'}, {'measure': 'Need for a surgical intervention', 'timeFrame': '2 and 6 months following treatment'}, {'measure': 'Improvement in the hemoglobin levels', 'timeFrame': '2 and 6 months following treatment'}, {'measure': 'Development of side effects: hot flushes, nausea,vomiting, headache, thrombophlebitis', 'timeFrame': '2 and 6 months following treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Leiomyoma', 'perimenopause', 'aromatase inhibitor'], 'conditions': ['Symptomatic or Large Uterine Fibroids']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Perimenopausal women (≥ 50 years) with symptomatic uterine leiomyomas (menometrorrhagia, pressure symptoms, urinary retention, pelvic pain) or those with large leiomyomas ≥ 7 cms\n\nExclusion Criteria:\n\n1. Women \\<50 years of age\n2. Postmenopausal women\n3. Women with impaired renal function\n4. Oral treatment with any type of estrogen or progesterone more recently than 1 month\n5. History of venous thromboembolism\n6. Any contraindication for Magnetic Resonance Imaging (MRI)'}, 'identificationModule': {'nctId': 'NCT00945360', 'briefTitle': 'Aromatase Inhibitors for Treatment of Uterine Leiomyomas', 'organization': {'class': 'OTHER', 'fullName': 'American University of Beirut Medical Center'}, 'officialTitle': 'Aromatase Inhibitors for the Prevention of the Growth of Uterine Leiomyomas in Perimenopausal Women: A Pilot Study', 'orgStudyIdInfo': {'id': 'OGY.AN.08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'aromatase inhibitors: Letrozole', 'description': 'All consenting patients will be started on Letrozole at a dose of 2.5 mg/day for 8 weeks.', 'interventionNames': ['Drug: Letrozole (aromatase inhibitor)']}], 'interventions': [{'name': 'Letrozole (aromatase inhibitor)', 'type': 'DRUG', 'otherNames': ['Letrozole'], 'description': 'Letrozole at a dose of 2.5 mg/day for 8 weeks.', 'armGroupLabels': ['aromatase inhibitors: Letrozole']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beirut', 'country': 'Lebanon', 'facility': 'American University of Beirut', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}], 'overallOfficials': [{'name': 'Anwar H Nassar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'American University of Beirut Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'American University of Beirut Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Anwar Nassar, MD/Associate Professor', 'oldOrganization': 'American University of Beirut Medical Center'}}}}