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Three-Year Trial on a New Testosterone Gel

Primary Purpose

Hypogonadism

Status
Unknown status
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Testosterone Gel Wolff
Sponsored by
University Hospital Muenster
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypogonadism focused on measuring Hypogonadism, Testosterone, Substitution

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • University Clinic Charité, Division of Urology
  • Franziskus-Hospital, Division of Urology
  • University Clinic Bonn, Division of Dermatology
  • Medical University Clinic II, Division of Internal Medicine/Andrology
  • University Clinic Essen, Division of Internal Medicine
  • J.-W. Goethe University, Medical Clinic I, Division of Internal Medicine
  • University Clinic Giessen, Division of Dermatology/Andrology
  • University Clinic Halle Wittenberg, Division of Urology/Andrology
  • Endokrinologikum Hamburg
  • University Medical Clinic Hannover
  • University Clinic Leipzig, Division of Dermatology/Andrology
  • Otto-von-Guerike-University, Clinic of Endocrinology
  • Phillips-University-Clinic Marburg, Division of Dermatology/Andrology
  • Insitute of Reproductive Medicine of the University
  • Private Practice of Urology

Outcomes

Primary Outcome Measures

testosterone levels

Secondary Outcome Measures

hormones
sexual function and mood disorder (questionnaire)
compliance (drug accountability)

Full Information

First Posted
September 12, 2005
Last Updated
May 12, 2006
Sponsor
University Hospital Muenster
Collaborators
Dr. August Wolff GmbH & Co. KG Arzneimittel
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1. Study Identification

Unique Protocol Identification Number
NCT00204269
Brief Title
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

2. Study Status

Record Verification Date
May 2006
Overall Recruitment Status
Unknown status
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital Muenster
Collaborators
Dr. August Wolff GmbH & Co. KG Arzneimittel

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadism
Keywords
Hypogonadism, Testosterone, Substitution

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Testosterone Gel Wolff
Primary Outcome Measure Information:
Title
testosterone levels
Secondary Outcome Measure Information:
Title
hormones
Title
sexual function and mood disorder (questionnaire)
Title
compliance (drug accountability)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eberhard Nieschlag, Prof. Dr.
Organizational Affiliation
Institute of Reproductive Medicine of the University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Clinic Charité, Division of Urology
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Franziskus-Hospital, Division of Urology
City
Bielefeld
ZIP/Postal Code
33615
Country
Germany
Facility Name
University Clinic Bonn, Division of Dermatology
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Medical University Clinic II, Division of Internal Medicine/Andrology
City
Cologne
ZIP/Postal Code
50924
Country
Germany
Facility Name
University Clinic Essen, Division of Internal Medicine
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
J.-W. Goethe University, Medical Clinic I, Division of Internal Medicine
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
University Clinic Giessen, Division of Dermatology/Andrology
City
Giessen
ZIP/Postal Code
35385
Country
Germany
Facility Name
University Clinic Halle Wittenberg, Division of Urology/Andrology
City
Halle (Saale)
ZIP/Postal Code
06120
Country
Germany
Facility Name
Endokrinologikum Hamburg
City
Hamburg
ZIP/Postal Code
22767
Country
Germany
Facility Name
University Medical Clinic Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
University Clinic Leipzig, Division of Dermatology/Andrology
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Otto-von-Guerike-University, Clinic of Endocrinology
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Phillips-University-Clinic Marburg, Division of Dermatology/Andrology
City
Marburg
ZIP/Postal Code
35037
Country
Germany
Facility Name
Insitute of Reproductive Medicine of the University
City
Muenster
ZIP/Postal Code
48129
Country
Germany
Facility Name
Private Practice of Urology
City
Nuernberg
ZIP/Postal Code
90441
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
16061839
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.
Results Reference
background

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Three-Year Trial on a New Testosterone Gel

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