Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2025-12-25 @ 8:11 PM
Study NCT ID:
NCT00400335
Status:
COMPLETED
Last Update Posted:
2012-06-04
First Post:
2006-11-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007006', 'term': 'Hypogonadism'}, {'id': 'D005058', 'term': 'Eunuchism'}, {'id': 'D018761', 'term': 'Multiple Endocrine Neoplasia Type 1'}], 'ancestors': [{'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D009377', 'term': 'Multiple Endocrine Neoplasia'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009378', 'term': 'Neoplasms, Multiple Primary'}, {'id': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'statusVerifiedDate': '2011-02', 'lastUpdateSubmitDate': '2012-05-31', 'studyFirstSubmitDate': '2006-11-14', 'studyFirstSubmitQcDate': '2006-11-14', 'lastUpdatePostDateStruct': {'date': '2012-06-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-11-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'lab tests for relative bioavailability of testosterone and dutasteride,', 'timeFrame': 'days 1, 2, 3, 19, 20, 21 & 26-31'}], 'secondaryOutcomes': [{'measure': 'safety lab tests of various testosterone/dutasteride formulations,', 'timeFrame': 'days 1, 2, 3, 19, 20, 21 & 26-31.'}, {'measure': 'lab tests for additional pharmacokinetic parameters for testosterone & dutasteride,', 'timeFrame': 'days 1, 2, 3, 19, 20, 21 & 26-31.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Testosterone', 'Men', 'Hypogonadism', 'Dutasteride', 'DHT', 'Androgen deficiency'], 'conditions': ['Hypogonadism', 'Hypogonadism, Male']}, 'descriptionModule': {'briefSummary': 'The combination of testosterone and dutasteride is intended for use in hypogonadal men. This study will evaluate the bioavailability and pharmacokinetics of various doses of testosterone administered with and without dutasteride'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Are healthy.\n* Have a BMI within range of 19-32 kg/m2.\n* Have not taken dutasteride for one year, or finasteride for the past 3 months.\n* Have a screening PSA \\< 2.0ng/mL.\n\nExclusion criteria:\n\n* Have had or have breast or prostate cancer, sleep apnea, psychiatric illness, or any other clinically significant current condition.\n* Have a trigliceride level =500mg/dL.\n* Have abnormal thyroid or hormone levels.\n* Would donate more than 500 ML of blood over a 2 month period.\n* Physician does not think it is a good idea for you to participate in the trial.\n* Are unwilling to abstain from alcohol during the study.\n* Have a positive urine drug screen test.\n* Plan to change your smoking habits during the course of the trial.\n* Have Hepatitis C, Hepatitis B, or HIV.\n* Have a lab or ECG abnormality.\n* Have high or low blood pressure.\n* Have used of any investigational drug or device during the study or within 30 days prior to 1st dosing of study medication.'}, 'identificationModule': {'nctId': 'NCT00400335', 'briefTitle': 'Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'An Open Label Study to Evaluate the Impact of Novel Fixed-dose Testosterone/Dutasteride Combinations on the Relative Bioavailability of the Individual Dutasteride and Testosterone Components', 'orgStudyIdInfo': {'id': 'TDC106222'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Nanomilled testosterone', 'type': 'DRUG'}, {'name': 'commercially available dutasteride', 'type': 'DRUG'}, {'name': 'Nanomilled dutasteride', 'type': 'DRUG', 'otherNames': ['commercially available dutasteride', 'Nanomilled testosterone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98418', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}