Clinical trial NCT00204269: Three-Year Trial on a New Testosterone Gel
Official title: Three-Year Trial on a New Testosterone Gel: Clinical Efficacy, Tolerability and Compliance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hypogonadism
Keywords: Hypogonadism
Testosterone
Substitution
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
Collaborators: name: Dr. August Wolff GmbH & Co. KG Arzneimittel
First posted: 2005-09-20
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: testosterone levels
Secondary outcomes:
measure: hormones
measure: sexual function and mood disorder (questionnaire)
measure: compliance (drug accountability)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: University Clinic Charité, Division of Urology
city: Bielefeld
country: Germany
facility: Franziskus-Hospital, Division of Urology
city: Bonn
country: Germany
facility: University Clinic Bonn, Division of Dermatology
city: Cologne
country: Germany
facility: Medical University Clinic II, Division of Internal Medicine/Andrology
city: Essen
country: Germany
facility: University Clinic Essen, Division of Internal Medicine
city: Frankfurt
country: Germany
facility: J.-W. Goethe University, Medical Clinic I, Division of Internal Medicine
city: Giessen
country: Germany
facility: University Clinic Giessen, Division of Dermatology/Andrology
city: Halle (Saale)
country: Germany
facility: University Clinic Halle Wittenberg, Division of Urology/Andrology
city: Hamburg
country: Germany
facility: Endokrinologikum Hamburg
city: Hannover
country: Germany
facility: University Medical Clinic Hannover
city: Leipzig
country: Germany
facility: University Clinic Leipzig, Division of Dermatology/Andrology
city: Magdeburg
country: Germany
facility: Otto-von-Guerike-University, Clinic of Endocrinology
city: Marburg
country: Germany
facility: Phillips-University-Clinic Marburg, Division of Dermatology/Andrology
city: Muenster
country: Germany
facility: Insitute of Reproductive Medicine of the University
city: Nuernberg
country: Germany
facility: Private Practice of Urology
Study officials:
affiliation: Institute of Reproductive Medicine of the University
name: Eberhard Nieschlag, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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.