Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:45 PM
Study NCT ID:
NCT01021267
Status:
UNKNOWN
Last Update Posted:
2009-11-26
First Post:
2009-11-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Study to Assess the Influence of a Saw Palmetto Preparation in Patients With Benign Prostatic Hyperplasia (BPH) and Sexual Dysfunctions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2011-12-22', 'releaseDate': '2011-11-22'}, {'resetDate': '2020-02-17', 'releaseDate': '2020-02-06'}], 'estimatedResultsFirstSubmitDate': '2011-11-22'}}, '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': 'C040972', 'term': 'saw palmetto extract'}, {'id': 'C571812', 'term': 'Prostasan'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2010-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-11-25', 'studyFirstSubmitDate': '2009-11-25', 'studyFirstSubmitQcDate': '2009-11-25', 'lastUpdatePostDateStruct': {'date': '2009-11-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of the brief Sexual Function Inventory', 'timeFrame': 'day 0 and day 56'}], 'secondaryOutcomes': [{'measure': 'change in IPSS change in Urolife Quality of Life questionnaire', 'timeFrame': 'day 0 and day 56'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['sexual dysfunctions', 'benign prostatic hyperplasia', 'saw palmetto'], 'conditions': ['Sexual Dysfunctions in Men With Benign Prostatic Hyperplasia']}, 'descriptionModule': {'briefSummary': 'Assessment in an open trial if a standardized saw palmetto preparation has a positive influence on sexual dysfunctions in patients with BPH and sexual dysfunctions.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with BPH and sexual dysfunctions (erectile dysfunction or decrease in libido)\n* IPSS \\> 4\n* BSFI, sexual drive questions \\< 5\n\nExclusion Criteria:\n\n* Lack of libido which is due to a psychic disease or a depressive mood -Excessivly strong lack of libido in the judgement of the investigator within the last two months\n* Patients with severe vascular disorders (microangiopathies)\n* Patients with known neuropathies\n* Severe diabetes mellitus\n* Patients with hypertension who are for less than two months on a stable antihypertensive medication\n* Known bad compliance of the patient'}, 'identificationModule': {'nctId': 'NCT01021267', 'briefTitle': 'Clinical Study to Assess the Influence of a Saw Palmetto Preparation in Patients With Benign Prostatic Hyperplasia (BPH) and Sexual Dysfunctions', 'organization': {'class': 'INDUSTRY', 'fullName': 'A. Vogel AG'}, 'officialTitle': 'Clinical Pilot Trial on the Influence of a Saw Palmetto Berry Preparation on Sexual Functions in Patients With Benign Prostatic Hyperplasia', 'orgStudyIdInfo': {'id': '920136'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Saw palmetto berry extract', 'description': 'Saw palmetto berry extract, organic saw palmetto, ethanolic extract 96%', 'interventionNames': ['Drug: Saw palmetto berry extract']}], 'interventions': [{'name': 'Saw palmetto berry extract', 'type': 'DRUG', 'otherNames': ['Prostasan'], 'description': '1x daily 1 capsule containing 320mg lipophilic extract', 'armGroupLabels': ['Saw palmetto berry extract']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7000', 'city': 'Chur', 'country': 'Switzerland', 'facility': 'Dr. Eugen Riedi', 'geoPoint': {'lat': 46.84986, 'lon': 9.53287}}], 'centralContacts': [{'name': 'Andy Suter, M.Sc.', 'role': 'CONTACT', 'email': 'a.suter@bioforce.ch', 'phone': '0041714546203'}], 'overallOfficials': [{'name': 'Eugen Riedi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'independent'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'A. Vogel AG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of London', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Andy Suter, Head of Med. Dept.', 'oldOrganization': 'Bioforce AG'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2011-11-22', 'type': 'RELEASE'}, {'date': '2011-12-22', 'type': 'RESET'}, {'date': '2020-02-06', 'type': 'RELEASE'}, {'date': '2020-02-17', 'type': 'RESET'}], 'unpostedResponsibleParty': ', Study coordinator, A. Vogel AG'}}}}