Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2026-01-04 @ 5:34 PM
Study NCT ID:
NCT06570135
Status:
RECRUITING
Last Update Posted:
2025-04-17
First Post:
2024-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brain Activity During Sexual Behavior in Patients With Primary Premature Ejaculation a Clinical Trial
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-14', 'studyFirstSubmitDate': '2024-07-29', 'studyFirstSubmitQcDate': '2024-08-22', 'lastUpdatePostDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Results of near-infrared brain functional imaging', 'timeFrame': '1 hours', 'description': 'Data on changes in oxygenated hemoglobin concentration'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Premature Ejaculation']}, 'descriptionModule': {'briefSummary': 'This is a controlled study of patients with and without primary premature ejaculation. It is based on near-infrared spectroscopy (NIRS) functional brain imaging to detect and compare changes in brain activity in resting and task states (Simulated Sex) between the two groups of patients.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria (primary premature ejaculation subjects):\n\n* patients' age varied from 18 to 45 years；\n* patients met the 2014 International Society for Sexual Medicine (ISSM) definition criteria for PPE；\n* patients had a stable, heterosexual relationship with a single sexually active female partner for at least 6 months and with at least two sexual intercourses a week and kept stable during the study period;\n* Patients with premature ejaculation lasting longer than 6 months；\n* patients were identified if their scores were higher than 9 on the Chinese version of Premature Ejaculation Diagnostic Tool (PEDT);\n* patients had no history of any previous therapies for PE or had recently stopped the therapies for at least 3 months\n* patients had fully informed consent, signed informed consent form\n\nInclusion Criteria (Non-premature ejaculation subjects):\n\n* Men between the ages of 18-45 years were included according to an age difference of \\<3 years between each patient and the primary premature ejaculation group, and if more than one volunteer was eligible at the same time, the one with the closest age was selected；\n* Patient does not meet the 2014 International Society for Sexual Medicine (ISSM) criteria for defining premature ejaculation；\n* patients had a stable, heterosexual relationship with a single sexually active female partner for at least 6 months and with at least two sexual intercourses a week and kept stable during the study period;\n* patients had fully informed consent, signed informed consent form；\n\nExclusion Criteria:\n\n* patients were diagnosed with secondary PE, variable PE, and subjective PE;\n* patients were using medications for endocrinological, metabolic, chronic systemic, or psychiatric diseases;\n* patients were abusing alcohol or illegal drugs；\n* patients were diagnosed with erectile dysfunction (ED) if their scores were \\<21 on the abridged five-item International Index of Erectile Function (IIEF-5)\n* patients were diagnosed with sexual hormone abnormalities, hyperthyroidism, hypothyroidism, Peyronie's disease, prostatitis, urethritis, or urinary tract infection;\n* patients with head injuries that prevent them from completing near-infrared light brain function imaging\n* Patients with severe schizophrenia, anxiety, depression or other neurological symptoms or poor compliance"}, 'identificationModule': {'nctId': 'NCT06570135', 'briefTitle': 'Brain Activity During Sexual Behavior in Patients With Primary Premature Ejaculation a Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital'}, 'officialTitle': 'Brain Activity During Sexual Behavior in Patients With Primary Premature Ejaculation a Clinical Trial', 'orgStudyIdInfo': {'id': 'KY20242242'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'premature ejaculation group', 'interventionNames': ['Diagnostic Test: Detecting Brain Activity with Functional Near Infrared Spectroscopy']}, {'type': 'EXPERIMENTAL', 'label': 'Non-premature ejaculation group', 'interventionNames': ['Diagnostic Test: Detecting Brain Activity with Functional Near Infrared Spectroscopy']}], 'interventions': [{'name': 'Detecting Brain Activity with Functional Near Infrared Spectroscopy', 'type': 'DIAGNOSTIC_TEST', 'description': 'Use a functional near-infrared spectroscopy to detect brain activity in the two groups of subjects during resting state and task state.', 'armGroupLabels': ['Non-premature ejaculation group', 'premature ejaculation group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70032', 'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weijun Qin, Dr', 'role': 'CONTACT'}], 'facility': 'Air Force Military Medical University', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'zip': '70032', 'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weijun Qin, M.D', 'role': 'CONTACT', 'email': 'mengxl69@163.com', 'phone': '13730192056', 'phoneExt': '13730192056'}], 'facility': 'Air Force Military Medical University', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Weijun Qin, M.D', 'role': 'CONTACT', 'email': 'qinwj@fmmu.edu.cn', 'phone': '13572501300'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xijing Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}