Three-Year Trial on a New Testosterone Gel

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2006 by University Hospital Muenster.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Dr. August Wolff GmbH & Co. KG Arzneimittel
Information provided by:
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT00204269
First received: September 12, 2005
Last updated: May 12, 2006
Last verified: May 2006
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Three-Year Trial on a New Testosterone Gel: Clinical Efficacy, Tolerability and Compliance

Resource links provided by NLM:


Further study details as provided by University Hospital Muenster:

Primary Outcome Measures:
  • testosterone levels

Secondary Outcome Measures:
  • hormones
  • sexual function and mood disorder (questionnaire)
  • compliance (drug accountability)

Estimated Enrollment: 100
Study Start Date: January 2003
Estimated Study Completion Date: September 2006
Detailed Description:

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
Criteria

Inclusion Criteria:

men with

  • hypergonadotropic hypogonadism
  • hypogonadotropic hypogonadism
  • late-onset hypogonadism

combined with an initial Testosterone serum level of < 11 nmol/l

Exclusion Criteria:

  • known or suspected carcinoma of the prostate
  • clinically relevant abnormalities in clinical chemistry or haematology
  • any severe medical conditions at the opinion of the investigator
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00204269

Locations
Germany
University Clinic Charité, Division of Urology
Berlin, Germany, 10117
Franziskus-Hospital, Division of Urology
Bielefeld, Germany, 33615
University Clinic Bonn, Division of Dermatology
Bonn, Germany, 53105
Medical University Clinic II, Division of Internal Medicine/Andrology
Cologne, Germany, 50924
University Clinic Essen, Division of Internal Medicine
Essen, Germany, 45147
J.-W. Goethe University, Medical Clinic I, Division of Internal Medicine
Frankfurt, Germany, 60590
University Clinic Giessen, Division of Dermatology/Andrology
Giessen, Germany, 35385
University Clinic Halle Wittenberg, Division of Urology/Andrology
Halle (Saale), Germany, 06120
Endokrinologikum Hamburg
Hamburg, Germany, 22767
University Medical Clinic Hannover
Hannover, Germany, 30625
University Clinic Leipzig, Division of Dermatology/Andrology
Leipzig, Germany, 04103
Otto-von-Guerike-University, Clinic of Endocrinology
Magdeburg, Germany, 39120
Phillips-University-Clinic Marburg, Division of Dermatology/Andrology
Marburg, Germany, 35037
Insitute of Reproductive Medicine of the University
Muenster, Germany, 48129
Private Practice of Urology
Nuernberg, Germany, 90441
Sponsors and Collaborators
University Hospital Muenster
Dr. August Wolff GmbH & Co. KG Arzneimittel
Investigators
Principal Investigator: Eberhard Nieschlag, Prof. Dr. Institute of Reproductive Medicine of the University
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00204269     History of Changes
Other Study ID Numbers: IRM 2002/37, TGT-04/2002
Study First Received: September 12, 2005
Last Updated: May 12, 2006
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Muenster:
Hypogonadism
Testosterone
Substitution

Additional relevant MeSH terms:
Hypogonadism
Endocrine System Diseases
Gonadal Disorders
Methyltestosterone
Testosterone
Testosterone 17 beta-cypionate
Testosterone enanthate
Testosterone undecanoate
Anabolic Agents
Androgens
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014