Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2025-12-26 @ 2:54 AM
Study NCT ID:
NCT01203202
Status:
COMPLETED
Last Update Posted:
2012-10-03
First Post:
2010-09-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase 2 Trial of PED-1 and PED-2 in Male Patients With Premature Ejaculation
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002997', 'term': 'Clomipramine'}], 'ancestors': [{'id': 'D003984', 'term': 'Dibenzazepines'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-01', 'studyFirstSubmitDate': '2010-09-14', 'studyFirstSubmitQcDate': '2010-09-14', 'lastUpdatePostDateStruct': {'date': '2012-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fold cahnges of Intraviginal ejaculation latency time (IELT)', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'Drug coitus interval time', 'timeFrame': '4 week'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PE', 'IELT', 'DCIT'], 'conditions': ['Premature Ejaculation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate whether PED-1 (15mg) and PED-2 (30mg) are tolerable and effective in the treatment of premature ejaculation.', 'detailedDescription': 'This study is to evaluate whether PED-1 and PED2 are tolerable and effective in the treatment of premature ejaculation. The patients will be randomized and allocated to three treatment groups into placebo, PED-1, and PED-2. The creteria for IELT for enrollment will be \\> or =2 min in the at least 75% of the sexual intercourse. To diagnosis premature ejaculation, the PEDT will be used. The patients ungone drug free baseline line period will take test drugs for 4 weeks.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent for subjects and partdners\n* Men 20-65\n* stable monogamous relation at least for 6 mn\n* PEDT more than 9\n* at least 6 Mn of premature ejaculation Hx\n* IELT of =\\< 2 min in \\>= 75% of evaluable events during 4 week secreening period\n\nExclusion Criteria:\n\n* Hx of medical or psychiartric illness\n* erectile dysfunction (\\<21 IIEF EF domain score) or other forms of sexual dysfunction\n* Partner sexual dysfunction\n* known hypersensitivity to clomipramine and contraindications for clomipramine'}, 'identificationModule': {'nctId': 'NCT01203202', 'briefTitle': 'Phase 2 Trial of PED-1 and PED-2 in Male Patients With Premature Ejaculation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Symyoo'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Fixed Dose, Parallel Grouped Clinical Study to Evaluate the Tolerability and to Determine the Adequate Dosage of PED-1 and PED-2 in Male Patients With Premature Ejaculation', 'orgStudyIdInfo': {'id': 'CTC PE 02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'PED 0', 'description': 'placebo', 'interventionNames': ['Drug: Clomipramine']}, {'type': 'EXPERIMENTAL', 'label': 'PED 1', 'description': 'PED-1 (clomipramine 15mg)', 'interventionNames': ['Drug: Clomipramine']}, {'type': 'EXPERIMENTAL', 'label': 'PED-2', 'description': 'PED-2 (Clomipramine 30mg)', 'interventionNames': ['Drug: Clomipramine']}], 'interventions': [{'name': 'Clomipramine', 'type': 'DRUG', 'otherNames': ['PED-1', 'PED-2'], 'description': '15mg and 30mg on demand', 'armGroupLabels': ['PED 0', 'PED 1', 'PED-2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Ewha University Mok-dong Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': "Seoul St. Marry's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Whan-Seok Choi, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Seoul St. Marry's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Symyoo', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Whan-Seok Choi', 'oldOrganization': "Seoul St. Marry's Hospital"}}}}