Quality of Life With TESTIM®
LIFE
1 other identifier
observational
157
1 country
64
Brief Summary
The present non-interventional study is to document the testosterone levels in patients with clinical symptoms such as loss of sexual desire indicating hypogonadism (testosterone deficiency syndrome). During testosterone replacement therapy with TESTIM®, the changes in the quality of life - especially with respect to motivation, activity and fatigue - of hypogonadal patients will be documented and correlated with the testosterone levels during the course of therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2010
64 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 21, 2010
CompletedFirst Posted
Study publicly available on registry
June 22, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedDecember 22, 2011
December 1, 2011
1.1 years
June 21, 2010
December 21, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Serum Testosterone Level
Measured at Visit 1 (diagnosis), Visit 3 (month 3) and Visit 4 (month 6)
6 months
Secondary Outcomes (5)
Quality of Life - (determined by the MFI questionnaire)
6 months
Multidimensional Fatigue Inventory (MFI) - (based on 20 questions regarding QoL)
6 months
Loss of Libido - (determined by the International Index of Erectile Function (IIEF-5)
6 months
Aging Male Scale (AMS) - (17 questions regarding the discomfort associated with testosterone deficiency)
6 months
Laboratory Parameters: PSA and Haematocrit levels
6 months
Study Arms (1)
TESTIM® - drug given by prescription
Male patients with Hypogonadism
Eligibility Criteria
Private practices
You may qualify if:
- therapeutic need according to SPC
- written informed consent
You may not qualify if:
- contraindications according to SPC
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ferring Pharmaceuticalslead
- Ferring Arzneimittel GmbHcollaborator
Study Sites (64)
Investigational Site
Apolda, Germany
Investigational Site
Aschersleben, Germany
Investigational Site
Bad Bergzaben, Germany
Investigational Site
Bad Schönborn, Germany
Investigational Site
Bautzen, Germany
Investigational Site, Helene-Weigel-Platz 10
Berlin, Germany
Investigational Site, Kurfürstendamm 33
Berlin, Germany
Investigational Site, Königin-Elisabeth-Straße 1
Berlin, Germany
Investigational Site, Tempelhofer Damm 227
Berlin, Germany
Investigational Site, Turmstraße 82
Berlin, Germany
Investigational Site, Wilmersdorfer Straße 62
Berlin, Germany
Investigational site
Bielefeld, Germany
Investigational Site
Bramsche, Germany
Investigational Site, Humboldtstraße 4
Braunschweig, Germany
Investigational site, Ritterbrunen 7
Braunschweig, Germany
Investigational Site, Dr.-Franz-Mertens-Straße 8
Bremerhaven, Germany
Investigational Site
Bremerhaven, Germany
Investigational Site
Büdingen, Germany
Investigational Site, Carl-von-Ossietzky-Straße 151
Chemnitz, Germany
Investigational Site, Clausstraße 44
Chemnitz, Germany
Investigational Site, Unritzstraße 21 c
Chemnitz, Germany
Investigational Site
Cologne, Germany
Investigational Site
Dortmund, Germany
Investigational Site
Dossenheim, Germany
Investigational Site
Düsseldorf, Germany
Investigational Site
Forchheim, Germany
Investigational Site, Eschersheimer Landstr. 544
Frankfurt, Germany
Investigational Site, Im Steinbügel 13
Frankfurt, Germany
Investigational Site
Freiberg, Germany
Investigational Site
Fulda, Germany
Investigational site
Gera, Germany
Investigational Site
Greifswald, Germany
Investigational Site
Halle, Germany
Investigational Site, Neuenfelder Straße 96
Hamburg, Germany
Investigational Site, Sand 35
Hamburg, Germany
Investigational Site, Schweriner Straße 25
Hamburg, Germany
Investigational Site, Tangstedter Landstraße 77
Hamburg, Germany
Investigational Site
Heilbronn, Germany
Investigational Site
Henningsdorf, Germany
Investigational Site
Hermsdorf, Germany
Investigational Site
Kamenz, Germany
Investigational Site
Kulmbach, Germany
Investigational Site
Landsberg/Lech, Germany
Investigational Site
Langenfeld, Germany
Investigational Site
Lübeck, Germany
Investigational Site
Mühlhausen, Germany
Investigational Site
München, Germany
Investigational Site
Neustadt, Germany
Investigational Site, Am Museumsturm 4
Nordhorn, Germany
Investigational Site, Osnabrücker Str. 1
Nordhorn, Germany
Investigational Site
Nuremberg, Germany
Investigational Site
Offenbach, Germany
Investigational Site
Paderborn, Germany
Investigational Site
Pulheim, Germany
Investigational Site
Ribnitz-Damgarten, Germany
Investigational Site
Rostock, Germany
Investigational Site
Rottweil, Germany
Investigational Site
Rüttenscheid, Germany
Investigational Site
Schwerte, Germany
Investigational Site
Tostedt, Germany
Investigational Site
Tönisvorst, Germany
Investigational Site
Weinheim, Germany
Investigational Site
Wilhelmshaven, Germany
Investigational Site
Wolfsburg, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Development Support
Ferring Pharmaceuticals
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2010
First Posted
June 22, 2010
Study Start
May 1, 2010
Primary Completion
June 1, 2011
Study Completion
July 1, 2011
Last Updated
December 22, 2011
Record last verified: 2011-12