Three-Year Trial on a New Testosterone Gel - Full Text View

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

ChemIDplus related topics:

Testosterone Methyltestosterone Oxymesterone Testosterone enanthate Testosterone Propionate Testosterone undecanoate

U.S. FDA Resources

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

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

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

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

Sponsors and Collaborators

University Hospital Muenster

Dr. August Wolff GmbH & Co

Investigators


Principal Investigator:	Eberhard Nieschlag, Prof. Dr.	Institute of Reproductive Medicine of the University

More Information

Publications:

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.

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

Keywords provided by University Hospital Muenster:

Hypogonadism

Testosterone

Substitution

Study placed in the following topic categories:

Testosterone

Hypogonadism

Gonadal Disorders

Endocrine System Diseases

Methyltestosterone

Endocrinopathy

Testosterone 17 beta-cypionate

Additional relevant MeSH terms:

Anabolic Agents

Antineoplastic Agents, Hormonal

Antineoplastic Agents

Therapeutic Uses

Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists

Hormones

Pharmacologic Actions

Androgens

ClinicalTrials.gov processed this record on October 16, 2008

Sponsors and Collaborators:	University Hospital Muenster Dr. August Wolff GmbH & Co
Information provided by:	University Hospital Muenster
ClinicalTrials.gov Identifier:	NCT00204269