Quality of Life With TESTIM®

Completed

• Conditions: Hypogonadism

• Registration Number: NCT01148433
• Lead Sponsor: Ferring Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-06-21
• Study First Submitted QC: 2010-06-21
• Study First Posted: 2010-06-22
• Primary Completion: 2011-06
• Study Completion: 2011-07
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-21
• Last Update Posted: 2011-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 157

Inclusion Criteria

• therapeutic need according to SPC
• written informed consent

Exclusion Criteria

• contraindications according to SPC

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum Testosterone Level	6 months	Measured at Visit 1 (diagnosis), Visit 3 (month 3) and Visit 4 (month 6)

Secondary Outcome Measures

Name	Time	Method
Quality of Life - (determined by the MFI questionnaire)	6 months	Determined at Visit 2 (month 0), Visit 3 (month 3) and Visit 4 (month 6)
Multidimensional Fatigue Inventory (MFI) - (based on 20 questions regarding QoL)	6 months	Used at Visit 2 (month 0), Visit 3 (month 3) and Visit 4 (month 6)
Loss of Libido - (determined by the International Index of Erectile Function (IIEF-5)	6 months	Used at Visit 2 (month 0), Visit 3 (month 3) and Visit 4 (month 6)
Aging Male Scale (AMS) - (17 questions regarding the discomfort associated with testosterone deficiency)	6 months	Used at Visit 2 (month 0), Visit 3 (month 3) and Visit 4 (month 6)
Laboratory Parameters: PSA and Haematocrit levels	6 months	Measured at Visit 1 (diagnosis), Visit 3 (month 3) and Visit 4 (month 6)

Trial Locations

Locations (22)

Investigational Site, Helene-Weigel-Platz 10; 🇩🇪 Berlin, Germany

Investigational Site, Königin-Elisabeth-Straße 1; 🇩🇪 Berlin, Germany

Investigational Site; 🇩🇪 Wolfsburg, Germany

Investigational Site, Turmstraße 82; 🇩🇪 Berlin, Germany

Investigational Site, Tempelhofer Damm 227; 🇩🇪 Berlin, Germany

Investigational site, Ritterbrunen 7; 🇩🇪 Braunschweig, Germany

Investigational site; 🇩🇪 Gera, Germany

Investigational Site, Wilmersdorfer Straße 62; 🇩🇪 Berlin, Germany

Investigational Site, Unritzstraße 21 c; 🇩🇪 Chemnitz, Germany

Investigational Site, Dr.-Franz-Mertens-Straße 8; 🇩🇪 Bremerhaven, Germany

Investigational Site, Kurfürstendamm 33; 🇩🇪 Berlin, Germany

Investigational Site, Humboldtstraße 4; 🇩🇪 Braunschweig, Germany

Investigational Site, Clausstraße 44; 🇩🇪 Chemnitz, Germany

Investigational Site, Carl-von-Ossietzky-Straße 151; 🇩🇪 Chemnitz, Germany

Investigational Site, Eschersheimer Landstr. 544; 🇩🇪 Frankfurt, Germany

Investigational Site, Im Steinbügel 13; 🇩🇪 Frankfurt, Germany

Investigational Site, Neuenfelder Straße 96; 🇩🇪 Hamburg, Germany

Investigational Site, Schweriner Straße 25; 🇩🇪 Hamburg, Germany

Investigational Site, Tangstedter Landstraße 77; 🇩🇪 Hamburg, Germany

Investigational Site, Am Museumsturm 4; 🇩🇪 Nordhorn, Germany

Investigational Site, Sand 35; 🇩🇪 Hamburg, Germany

Investigational Site, Osnabrücker Str. 1; 🇩🇪 Nordhorn, Germany