Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2026-03-29 @ 3:12 AM
Study NCT ID:
NCT00597051
Status:
COMPLETED
Last Update Posted:
2008-01-17
First Post:
2008-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of 3 Doses of ARD-0403 in Testosterone Deficient Men
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007006', 'term': 'Hypogonadism'}], 'ancestors': [{'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-01', 'completionDateStruct': {'date': '2006-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-01-16', 'studyFirstSubmitDate': '2008-01-08', 'studyFirstSubmitQcDate': '2008-01-16', 'lastUpdatePostDateStruct': {'date': '2008-01-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypogonadism']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine which dose, if any, results in testosterone levels within the normal range for men.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Testosterone deficiency\n* Normal BMI\n\nExclusion Criteria:\n\n* Previous treatment with testosterone replacement therapy within 4 weeks\n* Moderate-severe benign prostatic hypertrophy, or prostatic cancer\n* Haematocrit \\>50%'}, 'identificationModule': {'nctId': 'NCT00597051', 'acronym': 'ARD-0403-001', 'briefTitle': 'Study of 3 Doses of ARD-0403 in Testosterone Deficient Men', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ardana Bioscience Ltd'}, 'officialTitle': 'A Phase II, Randomized, Double-Blind, Placebo-Controlled, Cross-Over, Multi-Centre Study of the Pharmacokinetics and Tolerability of 3 Different Doses of ARD-0403 in Testosterone Deficient Men', 'orgStudyIdInfo': {'id': 'ARD-0403-001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ARD-0403', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '220 007', 'city': 'Minsk', 'country': 'Belarus', 'facility': 'Republican Endocrinology Center Hospital', 'geoPoint': {'lat': 53.90019, 'lon': 27.56653}}], 'overallOfficials': [{'name': 'Tatiana Mokhort, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Republican Endocrinology Center Hospital, Minsk, Republic of Belarus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ardana Bioscience Ltd', 'class': 'INDUSTRY'}}}}