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| Sponsor: | University Hospital Muenster |
|---|---|
| Collaborator: |
Dr. August Wolff GmbH & Co |
| Information provided by: | University Hospital Muenster |
| ClinicalTrials.gov Identifier: | NCT00204269 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypogonadism |
Drug: Testosterone Gel Wolff |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Three-Year Trial on a New Testosterone Gel: Clinical Efficacy, Tolerability and Compliance |
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2003 |
| Estimated Study Completion Date: | September 2006 |
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).
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
men with
combined with an initial Testosterone serum level of < 11 nmol/l
Exclusion Criteria:
Contacts and Locations| Germany | |
| Insitute of Reproductive Medicine of the University | |
| Muenster, Germany, 48129 | |
| Franziskus-Hospital, Division of Urology | |
| Bielefeld, Germany, 33615 | |
| Medical University Clinic II, Division of Internal Medicine/Andrology | |
| Cologne, Germany, 50924 | |
| University Clinic Bonn, Division of Dermatology | |
| Bonn, Germany, 53105 | |
| University Clinic Essen, Division of Internal Medicine | |
| Essen, Germany, 45147 | |
| University Clinic Halle Wittenberg, Division of Urology/Andrology | |
| Halle (Saale), Germany, 06120 | |
| Endokrinologikum Hamburg | |
| Hamburg, Germany, 22767 | |
| University Clinic Giessen, Division of Dermatology/Andrology | |
| Giessen, Germany, 35385 | |
| University Clinic Leipzig, Division of Dermatology/Andrology | |
| Leipzig, Germany, 04103 | |
| University Clinic Charité, Division of Urology | |
| Berlin, Germany, 10117 | |
| Phillips-University-Clinic Marburg, Division of Dermatology/Andrology | |
| Marburg, Germany, 35037 | |
| Private Practice of Urology | |
| Nuernberg, Germany, 90441 | |
| Otto-von-Guerike-University, Clinic of Endocrinology | |
| Magdeburg, Germany, 39120 | |
| J.-W. Goethe University, Medical Clinic I, Division of Internal Medicine | |
| Frankfurt, Germany, 60590 | |
| University Medical Clinic Hannover | |
| Hannover, Germany, 30625 | |
| Principal Investigator: | Eberhard Nieschlag, Prof. Dr. | Institute of Reproductive Medicine of the University |
More Information
| Study ID Numbers: | IRM 2002/37, TGT-04/2002 |
| Study First Received: | September 12, 2005 |
| Last Updated: | May 12, 2006 |
| ClinicalTrials.gov Identifier: | NCT00204269 History of Changes |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
Hypogonadism Testosterone Substitution |
|
Antineoplastic Agents, Hormonal Gonadal Disorders Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Endocrine System Diseases Methyltestosterone Hormones |
Pharmacologic Actions Testosterone 17 beta-cypionate Anabolic Agents Testosterone Hypogonadism Therapeutic Uses Androgens |
