Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2026-01-10 @ 8:43 PM
Study NCT ID:
NCT00690950
Status:
UNKNOWN
Last Update Posted:
2008-06-05
First Post:
2008-06-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Determine the Improvement of the Symptoms of Benign Prostatic Hyperplasia (BPH) When Switching Subjects From Proscar to Avodart
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011470', 'term': 'Prostatic Hyperplasia'}], 'ancestors': [{'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068538', 'term': 'Dutasteride'}], 'ancestors': [{'id': 'D001378', 'term': 'Azasteroids'}, {'id': 'D013260', 'term': 'Steroids, Heterocyclic'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-06', 'lastUpdateSubmitDate': '2008-06-04', 'studyFirstSubmitDate': '2008-06-03', 'studyFirstSubmitQcDate': '2008-06-04', 'lastUpdatePostDateStruct': {'date': '2008-06-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Laboratory parameters: including serum testosterone, DHT level and PSA', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'volume measurements of TRUSP and PVR', 'timeFrame': '12 months'}, {'measure': 'A decrease in the AUASI', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['BPH'], 'conditions': ['Benign Prostatic Hyperplasia']}, 'descriptionModule': {'briefSummary': 'Hypothesis: Dutasteride will perform better than finasteride in decreasing prostate volume, improving symptoms based on International Prostate Symptom score,and lower pvr based on the scientific information that dutasteride inhibits both Type I and II 5-alpha-reducatase vs. finasteride which only inhibits the Type II enzyme'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male\n* Age 50-80\n* On finasteride for no less than 12 months\n* Willing to undergo all necessary test in the 12 month evaluation\n\nExclusion Criteria:\n\n* History of medication non-compliance\n* Unwillingness to undergo/tolerate 2 blood draws\n* Unwillingness to tolerate/undergo 2 TRUSP'}, 'identificationModule': {'nctId': 'NCT00690950', 'briefTitle': 'A Study to Determine the Improvement of the Symptoms of Benign Prostatic Hyperplasia (BPH) When Switching Subjects From Proscar to Avodart', 'organization': {'class': 'OTHER', 'fullName': 'Urologic Consultants of Southeastern PA'}, 'officialTitle': 'Switch Study: Are There Any Measurable Differences When Switching Patients on Finasteride Therapy to Dutasteride?', 'orgStudyIdInfo': {'id': '110895'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Dutasteride', 'type': 'DRUG', 'description': '0.5mg capsule, taken once daily for 12 months'}]}, 'contactsLocationsModule': {'locations': [{'zip': '19004', 'city': 'Bala-Cynwyd', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Urologic Consultants of Southeastern PA', 'geoPoint': {'lat': 40.00761, 'lon': -75.23407}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Urologic Consultants of Southeastern PA', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. Richard C. Harkaway', 'oldOrganization': 'Urologic consultants of Southeastern PA'}}}}