Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
100 participants
INTERVENTIONAL
2003-01-31
2006-09-30
Brief Summary
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Detailed Description
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A 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Testosterone Gel Wolff
Eligibility Criteria
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Inclusion Criteria
* hypergonadotropic hypogonadism
* hypogonadotropic hypogonadism
* late-onset hypogonadism
combined with an initial Testosterone serum level of \< 11 nmol/l
Exclusion Criteria
* clinically relevant abnormalities in clinical chemistry or haematology
* any severe medical conditions at the opinion of the investigator
18 Years
MALE
No
Sponsors
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Dr. August Wolff GmbH & Co. KG Arzneimittel
INDUSTRY
University Hospital Muenster
OTHER
Principal Investigators
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Eberhard Nieschlag, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Institute of Reproductive Medicine of the University
Locations
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University Clinic Charité, Division of Urology
Berlin, , Germany
Franziskus-Hospital, Division of Urology
Bielefeld, , Germany
University Clinic Bonn, Division of Dermatology
Bonn, , Germany
Medical University Clinic II, Division of Internal Medicine/Andrology
Cologne, , Germany
University Clinic Essen, Division of Internal Medicine
Essen, , Germany
J.-W. Goethe University, Medical Clinic I, Division of Internal Medicine
Frankfurt, , Germany
University Clinic Giessen, Division of Dermatology/Andrology
Giessen, , Germany
University Clinic Halle Wittenberg, Division of Urology/Andrology
Halle, , Germany
Endokrinologikum Hamburg
Hamburg, , Germany
University Medical Clinic Hannover
Hanover, , Germany
University Clinic Leipzig, Division of Dermatology/Andrology
Leipzig, , Germany
Otto-von-Guerike-University, Clinic of Endocrinology
Magdeburg, , Germany
Phillips-University-Clinic Marburg, Division of Dermatology/Andrology
Marburg, , Germany
Insitute of Reproductive Medicine of the University
Münster, , Germany
Private Practice of Urology
Nuremberg, , Germany
Countries
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References
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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.
Other Identifiers
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TGT-04/2002
Identifier Type: -
Identifier Source: secondary_id
IRM 2002/37
Identifier Type: -
Identifier Source: org_study_id