Quality of Life With TESTIM®

Hypogonadism Clinical Trial

— LIFE  

Official title:

Quality of Life With TESTIM® in Testosterone Replacement Therapy for Male Patients With Hypogonadism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01148433
• Other study ID #: FE999303 CS01
• Status: Completed
• Phase: N/A
• First received: June 21, 2010
• Last updated: December 21, 2011
• Start date: May 2010
• Est. completion date: July 2011

Study information

• Verified date: December 2011
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: July 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• therapeutic need according to SPC

• written informed consent

Exclusion Criteria:

• contraindications according to SPC

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypogonadism

Locations

Country	Name	City	State
Germany	Investigational Site	Apolda
Germany	Investigational Site	Aschersleben
Germany	Investigational Site	Bad Bergzabern
Germany	Investigational Site	Bad Schönborn
Germany	Investigational Site	Bautzen
Germany	Investigational Site, Helene-Weigel-Platz 10	Berlin
Germany	Investigational Site, Königin-Elisabeth-Straße 1	Berlin
Germany	Investigational Site, Kurfürstendamm 33	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	Bremerhaven
Germany	Investigational Site, Dr.-Franz-Mertens-Straße 8	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	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	Köln
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	Nürnberg
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	Tönisvorst
Germany	Investigational Site	Tostedt
Germany	Investigational Site	Weinheim
Germany	Investigational Site	Wilhelmshaven
Germany	Investigational Site	Wolfsburg

Sponsors (2)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals	Ferring Arzneimittel GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Testosterone Level	Measured at Visit 1 (diagnosis), Visit 3 (month 3) and Visit 4 (month 6)	6 months	No
Secondary	Quality of Life - (determined by the MFI questionnaire)	Determined at Visit 2 (month 0), Visit 3 (month 3) and Visit 4 (month 6)	6 months	No
Secondary	Multidimensional Fatigue Inventory (MFI) - (based on 20 questions regarding QoL)	Used at Visit 2 (month 0), Visit 3 (month 3) and Visit 4 (month 6)	6 months	No
Secondary	Loss of Libido - (determined by the International Index of Erectile Function (IIEF-5)	Used at Visit 2 (month 0), Visit 3 (month 3) and Visit 4 (month 6)	6 months	No
Secondary	Aging Male Scale (AMS) - (17 questions regarding the discomfort associated with testosterone deficiency)	Used at Visit 2 (month 0), Visit 3 (month 3) and Visit 4 (month 6)	6 months	No
Secondary	Laboratory Parameters: PSA and Haematocrit levels	Measured at Visit 1 (diagnosis), Visit 3 (month 3) and Visit 4 (month 6)	6 months	No