Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2025-12-29 @ 10:42 PM
Study NCT ID:
NCT01249703
Status:
UNKNOWN
Last Update Posted:
2010-11-30
First Post:
2010-11-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Early Diagnosis and Warning Role of Erectile Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007172', 'term': 'Erectile Dysfunction'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-01', 'completionDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-11-29', 'studyFirstSubmitDate': '2010-11-29', 'studyFirstSubmitQcDate': '2010-11-29', 'lastUpdatePostDateStruct': {'date': '2010-11-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Erectile Dysfunction', 'Endothelial Dysfunction']}, 'descriptionModule': {'briefSummary': '1. Find the early diagnostic markers of erectile dysfunction;\n2. Study the warning role of ED in some diseases.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'men with erectile dysfunction healthy men general male population', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male and at least 18 years of age.\n2. Provide signed informed consent.\n3. Have a history of erectile dysfunction (ED: defined as a consistent change in the quality of erection that adversely affects the subject's satisfaction with sexual intercourse) .\n4. Have a stable monogamous relationship with a female partner. To some subjects with poor sexual experience, re-evaluation would be conducted after a 4-weeks sex education.\n5. Make at least four sexual intercourse attempts with the female sexual study partner during the 4-week therapeutic period without medication.\n6. Agree not to use any other ED treatment for at least 4 weeks.\n\nExclusion Criteria:\n\n1. severe diseases (such as congestive heart failure, arrhythmia, significant renal or hepatic dysfunction and anemia);\n2. Had clinically noteworthy penile deformities, pelvic surgery or trauma of perineal region;\n3. Had received long-term pharmacotherapy (including antioxidant agents, vitamins and traditional Chinese drugs).\n4. An addiction problem (with a history of injection or administration of opium, poppy, heroin, hemp, morphine, cocaine, caffeine, ketamine and meperidine etc.)"}, 'identificationModule': {'nctId': 'NCT01249703', 'briefTitle': 'The Early Diagnosis and Warning Role of Erectile Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'The Early Diagnosis and Warning Role of Erectile Dysfunction:a Multi-institutional Clinical Study.', 'orgStudyIdInfo': {'id': 'Chunhua Deng'}}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chunhua Deng, MD, PhD', 'role': 'CONTACT', 'email': 'dch0313@163.com', 'phone': '(01186) 20-87333300'}, {'name': 'Yanping Huang, MD', 'role': 'CONTACT', 'email': 'hyppin@gmail.com', 'phone': '(01186) 20-87333300'}, {'name': 'Chunhua Deng, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The First Affiliated Hospital of Sun Yat-Sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Chunhua Deng, MD, PhD', 'role': 'CONTACT', 'email': 'dch0313@163.com', 'phone': '(01186)20-87333300'}, {'name': 'Yanping Huang, MD', 'role': 'CONTACT', 'email': 'hyppin@gmail.com', 'phone': '(01186)20-87333300'}], 'overallOfficials': [{'name': 'Chunhua Deng, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Urology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Chunhua Deng', 'oldOrganization': 'Department of Urology'}}}}