Clinical trial NCT01148433: Quality of Life With TESTIM®
Official title: Quality of Life With TESTIM® in Testosterone Replacement Therapy for Male Patients With Hypogonadism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypogonadism
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Ferring Arzneimittel GmbH
First posted: 2010-06-22
Enrollment: 157
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Private practices

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.


Eligibility criteria: Inclusion Criteria:

* therapeutic need according to SPC
* written informed consent

Exclusion Criteria:

* contraindications according to SPC

Primary outcomes:
measure: Serum Testosterone Level
timeFrame: 6 months
Secondary outcomes:
measure: Quality of Life - (determined by the MFI questionnaire)
timeFrame: 6 months
measure: Multidimensional Fatigue Inventory (MFI) - (based on 20 questions regarding QoL)
timeFrame: 6 months
measure: Loss of Libido - (determined by the International Index of Erectile Function (IIEF-5)
timeFrame: 6 months
measure: Aging Male Scale (AMS) - (17 questions regarding the discomfort associated with testosterone deficiency)
timeFrame: 6 months
measure: Laboratory Parameters: PSA and Haematocrit levels
timeFrame: 6 months
Other outcomes:
Locations:
city: Apolda
country: Germany
facility: Investigational Site
city: Aschersleben
country: Germany
facility: Investigational Site
city: Bad Bergzabern
country: Germany
facility: Investigational Site
city: Bad Schönborn
country: Germany
facility: Investigational Site
city: Bautzen
country: Germany
facility: Investigational Site
city: Berlin
country: Germany
facility: Investigational Site, Helene-Weigel-Platz 10
city: Berlin
country: Germany
facility: Investigational Site, Kurfürstendamm 33
city: Berlin
country: Germany
facility: Investigational Site, Königin-Elisabeth-Straße 1
city: Berlin
country: Germany
facility: Investigational Site, Tempelhofer Damm 227
city: Berlin
country: Germany
facility: Investigational Site, Turmstraße 82
city: Berlin
country: Germany
facility: Investigational Site, Wilmersdorfer Straße 62
city: Bielefeld
country: Germany
facility: Investigational site
city: Bramsche
country: Germany
facility: Investigational Site
city: Braunschweig
country: Germany
facility: Investigational Site, Humboldtstraße 4
city: Braunschweig
country: Germany
facility: Investigational site, Ritterbrunen 7
city: Bremerhaven
country: Germany
facility: Investigational Site, Dr.-Franz-Mertens-Straße 8
city: Bremerhaven
country: Germany
facility: Investigational Site
city: Büdingen
country: Germany
facility: Investigational Site
city: Chemnitz
country: Germany
facility: Investigational Site, Carl-von-Ossietzky-Straße 151
city: Chemnitz
country: Germany
facility: Investigational Site, Clausstraße 44
city: Chemnitz
country: Germany
facility: Investigational Site, Unritzstraße 21 c
city: Dortmund
country: Germany
facility: Investigational Site
city: Dossenheim
country: Germany
facility: Investigational Site
city: Düsseldorf
country: Germany
facility: Investigational Site
city: Forchheim
country: Germany
facility: Investigational Site
city: Frankfurt
country: Germany
facility: Investigational Site, Eschersheimer Landstr. 544
city: Frankfurt
country: Germany
facility: Investigational Site, Im Steinbügel 13
city: Freiberg
country: Germany
facility: Investigational Site
city: Fulda
country: Germany
facility: Investigational Site
city: Gera
country: Germany
facility: Investigational site
city: Greifswald
country: Germany
facility: Investigational Site
city: Halle
country: Germany
facility: Investigational Site
city: Hamburg
country: Germany
facility: Investigational Site, Neuenfelder Straße 96
city: Hamburg
country: Germany
facility: Investigational Site, Sand 35
city: Hamburg
country: Germany
facility: Investigational Site, Schweriner Straße 25
city: Hamburg
country: Germany
facility: Investigational Site, Tangstedter Landstraße 77
city: Heilbronn
country: Germany
facility: Investigational Site
city: Henningsdorf
country: Germany
facility: Investigational Site
city: Hermsdorf
country: Germany
facility: Investigational Site
city: Kamenz
country: Germany
facility: Investigational Site
city: Kulmbach
country: Germany
facility: Investigational Site
city: Köln
country: Germany
facility: Investigational Site
city: Landsberg/Lech
country: Germany
facility: Investigational Site
city: Langenfeld
country: Germany
facility: Investigational Site
city: Lübeck
country: Germany
facility: Investigational Site
city: Mühlhausen
country: Germany
facility: Investigational Site
city: München
country: Germany
facility: Investigational Site
city: Neustadt
country: Germany
facility: Investigational Site
city: Nordhorn
country: Germany
facility: Investigational Site, Am Museumsturm 4
city: Nordhorn
country: Germany
facility: Investigational Site, Osnabrücker Str. 1
city: Nürnberg
country: Germany
facility: Investigational Site
city: Offenbach
country: Germany
facility: Investigational Site
city: Paderborn
country: Germany
facility: Investigational Site
city: Pulheim
country: Germany
facility: Investigational Site
city: Ribnitz-Damgarten
country: Germany
facility: Investigational Site
city: Rostock
country: Germany
facility: Investigational Site
city: Rottweil
country: Germany
facility: Investigational Site
city: Rüttenscheid
country: Germany
facility: Investigational Site
city: Schwerte
country: Germany
facility: Investigational Site
city: Tostedt
country: Germany
facility: Investigational Site
city: Tönisvorst
country: Germany
facility: Investigational Site
city: Weinheim
country: Germany
facility: Investigational Site
city: Wilhelmshaven
country: Germany
facility: Investigational Site
city: Wolfsburg
country: Germany
facility: Investigational Site
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: