Three-Year Trial on a New Testosterone Gel
2 other identifiers
interventional
100
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2003
Typical duration for phase_3
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedMay 15, 2006
May 1, 2006
September 12, 2005
May 12, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
testosterone levels
Secondary Outcomes (3)
hormones
sexual function and mood disorder (questionnaire)
compliance (drug accountability)
Interventions
Eligibility Criteria
You may qualify if:
- men with
- hypergonadotropic hypogonadism
- hypogonadotropic hypogonadism
- late-onset hypogonadism
- combined with an initial Testosterone serum level of \< 11 nmol/l
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
University Clinic Charité, Division of Urology
Berlin, 10117, Germany
Franziskus-Hospital, Division of Urology
Bielefeld, 33615, Germany
University Clinic Bonn, Division of Dermatology
Bonn, 53105, Germany
Medical University Clinic II, Division of Internal Medicine/Andrology
Cologne, 50924, Germany
University Clinic Essen, Division of Internal Medicine
Essen, 45147, Germany
J.-W. Goethe University, Medical Clinic I, Division of Internal Medicine
Frankfurt, 60590, Germany
University Clinic Giessen, Division of Dermatology/Andrology
Giessen, 35385, Germany
University Clinic Halle Wittenberg, Division of Urology/Andrology
Halle, 06120, Germany
Endokrinologikum Hamburg
Hamburg, 22767, Germany
University Medical Clinic Hannover
Hanover, 30625, Germany
University Clinic Leipzig, Division of Dermatology/Andrology
Leipzig, 04103, Germany
Otto-von-Guerike-University, Clinic of Endocrinology
Magdeburg, 39120, Germany
Phillips-University-Clinic Marburg, Division of Dermatology/Andrology
Marburg, 35037, Germany
Insitute of Reproductive Medicine of the University
Münster, 48129, Germany
Private Practice of Urology
Nuremberg, 90441, Germany
Related Publications (1)
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.
PMID: 16061839BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eberhard Nieschlag, Prof. Dr.
Institute of Reproductive Medicine of the University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 20, 2005
Study Start
January 1, 2003
Study Completion
September 1, 2006
Last Updated
May 15, 2006
Record last verified: 2006-05