Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2025-12-26 @ 4:26 AM
Study NCT ID:
NCT04235192
Status:
UNKNOWN
Last Update Posted:
2020-01-21
First Post:
2020-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multicenter Case-control Study of Risk Factors for Premature Ejaculation in China's Shaanxi Province
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D061686', 'term': 'Premature Ejaculation'}], 'ancestors': [{'id': 'D000097910', 'term': 'Ejaculatory Dysfunction'}, {'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': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1340}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2020-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-15', 'studyFirstSubmitDate': '2020-01-15', 'studyFirstSubmitQcDate': '2020-01-15', 'lastUpdatePostDateStruct': {'date': '2020-01-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IELT', 'timeFrame': 'Within 6 months', 'description': 'Intra-vaginal Ejaculation Latency Time'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['risk factor'], 'conditions': ['Premature Ejaculation']}, 'descriptionModule': {'briefSummary': 'Through a multicenter case-control study on the risk factors of premature ejaculation in Shaanxi, to find out the related factors of the occurrence and development of premature ejaculation, to provide reference for personalized treatment, in order to improve the quality of sexual life of patients and partners.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with premature ejaculation in the outpatient department of the hospital were the case group, while patients without premature ejaculation in the outpatient department were the control group', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\) case group\n\n 1. 18-64 years old, regular sexual life \\> 6 months;\n 2. Self-report of premature ejaculation;\n 3. Able to complete questionnaires and scale scores independently. 2) control group\n\n <!-- -->\n\n 1. 18-64 years old, regular sexual life \\> 6 months;\n 2. Both partners are satisfied with their sexual life;\n 3. Able to complete questionnaires and scale scores independently.\n\nExclusion Criteria:\n\n* 1\\) case group\n\n 1. Those who are unable to have sex due to genital malformation;\n 2. Patients with serious cardiovascular and cerebrovascular diseases;\n 3. Severe mental disorders (history of epilepsy, mania, etc.);\n 4. Have a history of brain trauma;\n 5. People with a long history of substance abuse. 2) control group\n\n <!-- -->\n\n 1. Patients with a history of mental illness;\n 2. Oral selective serotonin (5-ht) reuptake inhibitors, tricyclic antidepressants, triazolidine antidepressants, tramadol and sedatives'}, 'identificationModule': {'nctId': 'NCT04235192', 'briefTitle': "A Multicenter Case-control Study of Risk Factors for Premature Ejaculation in China's Shaanxi Province", 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital'}, 'officialTitle': "A Multicenter Case-control Study of Risk Factors for Premature Ejaculation in China's Shaanxi Province", 'orgStudyIdInfo': {'id': '4222018004'}}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fei Wu, master', 'role': 'CONTACT', 'email': 'XJYYLLWYH@163.com', 'phone': '+86-029-84771794'}], 'facility': 'Xijing Hospital, Fourth Military Medical University', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Jianlin Yuan, doctor', 'role': 'CONTACT', 'email': 'jianliny@fmmu.edu.cn', 'phone': '+86-136-0912-3155'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xijing Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': "First Affiliated Hospital Xi'an Jiaotong University", 'class': 'OTHER'}, {'name': "Shaanxi Provincial People's Hospital", 'class': 'OTHER'}, {'name': "Xi'an No.3 Hospital", 'class': 'OTHER_GOV'}, {'name': 'Shaanxi Armed Police Corps Hospital', 'class': 'UNKNOWN'}, {'name': "Northwest Women's and Children's Hospital, Xi'an, Shaanxi", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}