Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2025-12-25 @ 8:43 PM
Study NCT ID:
NCT00204269
Status:
UNKNOWN
Last Update Posted:
2006-05-15
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Three-Year Trial on a New Testosterone Gel
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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-05', 'completionDateStruct': {'date': '2006-09'}, 'lastUpdateSubmitDate': '2006-05-12', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2006-05-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'testosterone levels'}], 'secondaryOutcomes': [{'measure': 'hormones'}, {'measure': 'sexual function and mood disorder (questionnaire)'}, {'measure': 'compliance (drug accountability)'}]}, 'conditionsModule': {'keywords': ['Hypogonadism', 'Testosterone', 'Substitution'], 'conditions': ['Hypogonadism']}, 'referencesModule': {'references': [{'pmid': '16061839', 'type': 'BACKGROUND', 'citation': 'Kuhnert B, Byrne M, Simoni M, Kopcke W, Gerss J, Lemmnitz G, Nieschlag E. Testosterone substitution with a new transdermal, hydroalcoholic gel applied to scrotal or non-scrotal skin: a multicentre trial. Eur J Endocrinol. 2005 Aug;153(2):317-26. doi: 10.1530/eje.1.01964.'}]}, 'descriptionModule': {'briefSummary': "The objective of the study is to examine the efficacy and tolerability of a three-year-Testosterone replacement therapy in hypogonadal patients as well as the patient's compliance. The replacement therapy will be performed with a new Testosterone Gel examined in previous trials as Testosteron Gel Wolff.", 'detailedDescription': "The objective of the study is to examine the efficacy and tolerability of a three-year-Testosterone replacement therapy in hypogonadal patients as well as the patient's compliance. The replacement therapy will be performed with a new Testosterone Gel examined in previous trials as Testosteron Gel Wolff (TGW).\n\nA minimum of 100 patients will be recruited and evenly distributed to two treatment arms. 1st arm: dermal (non-scrotal) application of TGW. 2nd arm: scrotal application of TGW."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nmen with\n\n* hypergonadotropic hypogonadism\n* hypogonadotropic hypogonadism\n* late-onset hypogonadism\n\ncombined with an initial Testosterone serum level of \\< 11 nmol/l\n\nExclusion Criteria:\n\n* known or suspected carcinoma of the prostate\n* clinically relevant abnormalities in clinical chemistry or haematology\n* any severe medical conditions at the opinion of the investigator'}, 'identificationModule': {'nctId': 'NCT00204269', 'briefTitle': 'Three-Year Trial on a New Testosterone Gel', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Muenster'}, 'officialTitle': 'Three-Year Trial on a New Testosterone Gel: Clinical Efficacy, Tolerability and Compliance', 'orgStudyIdInfo': {'id': 'IRM 2002/37'}, 'secondaryIdInfos': [{'id': 'TGT-04/2002'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Testosterone Gel Wolff', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'University Clinic Charité, Division of Urology', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '33615', 'city': 'Bielefeld', 'country': 'Germany', 'facility': 'Franziskus-Hospital, Division of Urology', 'geoPoint': {'lat': 52.03333, 'lon': 8.53333}}, {'zip': '53105', 'city': 'Bonn', 'country': 'Germany', 'facility': 'University Clinic Bonn, Division of Dermatology', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '50924', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Medical University Clinic II, Division of Internal Medicine/Andrology', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '45147', 'city': 'Essen', 'country': 'Germany', 'facility': 'University Clinic Essen, Division of Internal Medicine', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '60590', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'J.-W. Goethe University, Medical Clinic I, Division of Internal Medicine', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '35385', 'city': 'Giessen', 'country': 'Germany', 'facility': 'University Clinic Giessen, Division of Dermatology/Andrology', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}, {'zip': '06120', 'city': 'Halle', 'country': 'Germany', 'facility': 'University Clinic Halle Wittenberg, Division of Urology/Andrology', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'zip': '22767', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Endokrinologikum Hamburg', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '30625', 'city': 'Hanover', 'country': 'Germany', 'facility': 'University Medical Clinic Hannover', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '04103', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'University Clinic Leipzig, Division of Dermatology/Andrology', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '39120', 'city': 'Magdeburg', 'country': 'Germany', 'facility': 'Otto-von-Guerike-University, Clinic of Endocrinology', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}, {'zip': '35037', 'city': 'Marburg', 'country': 'Germany', 'facility': 'Phillips-University-Clinic Marburg, Division of Dermatology/Andrology', 'geoPoint': {'lat': 50.80904, 'lon': 8.77069}}, {'zip': '48129', 'city': 'Münster', 'country': 'Germany', 'facility': 'Insitute of Reproductive Medicine of the University', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '90441', 'city': 'Nuremberg', 'country': 'Germany', 'facility': 'Private Practice of Urology', 'geoPoint': {'lat': 49.45421, 'lon': 11.07752}}], 'overallOfficials': [{'name': 'Eberhard Nieschlag, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Reproductive Medicine of the University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Muenster', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dr. August Wolff GmbH & Co. KG Arzneimittel', 'class': 'INDUSTRY'}]}}}