Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2025-12-31 @ 7:30 AM
Study NCT ID:
NCT00401661
Status:
COMPLETED
Last Update Posted:
2009-09-15
First Post:
2006-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin
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': 'C047638', 'term': 'alfuzosin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'lastUpdateSubmitDate': '2009-09-14', 'studyFirstSubmitDate': '2006-11-17', 'studyFirstSubmitQcDate': '2006-11-17', 'lastUpdatePostDateStruct': {'date': '2009-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MSHQ Ejaculation score', 'timeFrame': 'End of treatment'}], 'secondaryOutcomes': [{'measure': 'MSHQ Ejaculation score', 'timeFrame': 'After 4 weeks of treatment'}, {'measure': 'MSHQ Ejaculation score', 'timeFrame': 'After 12 weeks of treatment'}, {'measure': 'Acute Urinary Retention', 'timeFrame': 'End of treatment'}, {'measure': 'Correlation between MSHQ and IPSS', 'timeFrame': 'End of treatment'}, {'measure': 'I-PSS total score', 'timeFrame': 'After 1 week of treatment'}, {'measure': 'I-PSS total score', 'timeFrame': 'After 4 weeks of treatment'}, {'measure': 'I-PSS total score', 'timeFrame': 'After 12 weeks of treatment'}, {'measure': 'I-PSS total score', 'timeFrame': 'End of treatment'}, {'measure': 'IPSS total score decrease = 3 points', 'timeFrame': 'End of treatment'}, {'measure': 'IPSS: filling sub-score', 'timeFrame': 'After 1 week of treatment'}, {'measure': 'IPSS: filling sub-score', 'timeFrame': 'After 4 weeks of treatment'}, {'measure': 'IPSS: filling sub-score', 'timeFrame': 'After 12 weeks of treatment'}, {'measure': 'IPSS: filling sub-score', 'timeFrame': 'End of treatment'}, {'measure': 'IPSS: nocturia symptoms sub-score', 'timeFrame': 'After 1 week of treatment'}, {'measure': 'IPSS: nocturia symptoms sub-score', 'timeFrame': 'After 4 weeks of treatment'}, {'measure': 'IPSS: nocturia symptoms sub-score', 'timeFrame': 'After 12 weeks of treatment'}, {'measure': 'IPSS: nocturia symptoms sub-score', 'timeFrame': 'End of treatment'}, {'measure': 'IPSS: voiding sub-score', 'timeFrame': 'After 1 week of treatment'}, {'measure': 'IPSS: voiding sub-score', 'timeFrame': 'After 4 weeks of treatment'}, {'measure': 'IPSS: voiding sub-score', 'timeFrame': 'After 12 weeks of treatment'}, {'measure': 'IPSS: voiding sub-score', 'timeFrame': 'End of treatment'}, {'measure': 'MSHQ ejaculation: erection sub-score', 'timeFrame': 'After 4 weeks of treatment'}, {'measure': 'MSHQ ejaculation: erection sub-score', 'timeFrame': 'After 12 weeks of treatment'}, {'measure': 'MSHQ ejaculation: erection sub-score', 'timeFrame': 'End of treatment'}, {'measure': 'MSHQ ejaculation: satisfaction sub-score', 'timeFrame': 'After 4 weeks of treatment'}, {'measure': 'MSHQ ejaculation: satisfaction sub-score', 'timeFrame': 'After 12 weeks of treatment'}, {'measure': 'MSHQ ejaculation: satisfaction sub-score', 'timeFrame': 'End of treatment'}, {'measure': 'Quality of Life', 'timeFrame': 'After 4 weeks of treatment'}, {'measure': 'Quality of Life', 'timeFrame': 'After 12 weeks of treatment'}, {'measure': 'Quality of Life', 'timeFrame': 'End of treatment'}]}, 'conditionsModule': {'conditions': ['Prostatic Hyperplasia']}, 'descriptionModule': {'briefSummary': 'Primary objective:\n\n* End-point improvement from baseline in Male Sexual Health Questionnaire Ejaculation domain (MSHQ-EjD)in men with lower urinary tract symptoms (LUTS)suggestive of benign prostatic hyperplasia (BPH) treated for 6 months with XATRAL 10mg once daily OD.\n\nSecondary objectives:\n\n* MSHQ-EjD improvement by visit\n* Improvement in International Prostate Symptom Score (IPSS) total score, voiding and filling subscores, nocturia and bother score at end-point and by visit\n* Onset of action of XATRAL 10mg OD\n* Tolerability of XATRAL 10mg OD including occurrence of acute urinary retention.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Patients suffering from moderate to severe LUTS suggestive of BPH\n* I-PSS total score ≥ 8\n* Patients sexually active\n\nExclusion criteria:\n\n* Known history of hepatic or severe renal insufficiency, unstable angina pectoris, concomitant life-threatening condition\n* Previous prostate surgery, minimally invasive procedure within 6 months prior to inclusion. Planned prostate biopsy, prostate surgery or minimally invasive procedure during the whole study period\n* Active urinary tract infection or prostatitis, neuropathic bladder, a diagnosed prostate cancer\n* Treatment with 5alpha-reductase inhibitors or phytotherapy within 6 months prior to inclusion, or alpha1-blockers within 30 days prior to inclusion\n* Patients receiving any treatment for erectile dysfunction (i.e. phosphodiesterase-5 inhibitors) at inclusion\n* History of postural hypotension or syncope\n* Known hypersensitivity to alfuzosin\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT00401661', 'acronym': 'SAMBA-Thailand', 'briefTitle': 'Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin 10mg Once Daily (XATRAL 10mg OD), Open, 24-week Study.', 'orgStudyIdInfo': {'id': 'ALFUS_L_01241'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Alfuzosin for 24 weeks', 'interventionNames': ['Drug: Alfuzosin']}], 'interventions': [{'name': 'Alfuzosin', 'type': 'DRUG', 'description': 'One tablet of 10mg once daily at the end of evening meal', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Natesumroeng Taweeporn', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Medical Affairs Study Director', 'oldOrganization': 'sanofi-aventis'}}}}