Quality of Life With TESTIM® (LIFE)

December 21, 2011 updated by: Ferring Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

157

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Apolda, Germany
        • Investigational Site
      • Aschersleben, Germany
        • Investigational Site
      • Bad Bergzabern, Germany
        • Investigational Site
      • Bad Schönborn, Germany
        • Investigational Site
      • Bautzen, Germany
        • Investigational Site
      • Berlin, 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
      • Bielefeld, Germany
        • Investigational Site
      • Bramsche, Germany
        • Investigational Site
      • Braunschweig, Germany
        • Investigational Site, Humboldtstraße 4
      • Braunschweig, Germany
        • Investigational site, Ritterbrunen 7
      • Bremerhaven, Germany
        • Investigational Site, Dr.-Franz-Mertens-Straße 8
      • Bremerhaven, Germany
        • Investigational Site
      • Büdingen, Germany
        • Investigational Site
      • Chemnitz, Germany
        • Investigational Site, Clausstraße 44
      • Chemnitz, Germany
        • Investigational Site, Unritzstraße 21 c
      • Chemnitz, Germany
        • Investigational Site, Carl-von-Ossietzky-Straße 151
      • Dortmund, Germany
        • Investigational Site
      • Dossenheim, Germany
        • Investigational Site
      • Düsseldorf, Germany
        • Investigational Site
      • Forchheim, Germany
        • Investigational Site
      • Frankfurt, Germany
        • Investigational Site, Eschersheimer Landstr. 544
      • Frankfurt, Germany
        • Investigational Site, Im Steinbügel 13
      • Freiberg, Germany
        • Investigational Site
      • Fulda, Germany
        • Investigational Site
      • Gera, Germany
        • Investigational Site
      • Greifswald, Germany
        • Investigational Site
      • Halle, Germany
        • Investigational Site
      • Hamburg, Germany
        • Investigational Site, Tangstedter Landstraße 77
      • Hamburg, Germany
        • Investigational Site, Neuenfelder Straße 96
      • Hamburg, Germany
        • Investigational Site, Sand 35
      • Hamburg, Germany
        • Investigational Site, Schweriner Straße 25
      • Heilbronn, Germany
        • Investigational Site
      • Henningsdorf, Germany
        • Investigational Site
      • Hermsdorf, Germany
        • Investigational Site
      • Kamenz, Germany
        • Investigational Site
      • Kulmbach, Germany
        • Investigational Site
      • Köln, 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
      • Nordhorn, Germany
        • Investigational Site, Am Museumsturm 4
      • Nordhorn, Germany
        • Investigational Site, Osnabrücker Str. 1
      • 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
      • Tostedt, Germany
        • Investigational Site
      • Tönisvorst, Germany
        • Investigational Site
      • Weinheim, Germany
        • Investigational Site
      • Wilhelmshaven, Germany
        • Investigational Site
      • Wolfsburg, Germany
        • Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Private practices

Description

Inclusion Criteria:

  • therapeutic need according to SPC
  • written informed consent

Exclusion Criteria:

  • contraindications according to SPC

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
TESTIM® - drug given by prescription
Male patients with Hypogonadism

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Testosterone Level
Time Frame: 6 months
Measured at Visit 1 (diagnosis), Visit 3 (month 3) and Visit 4 (month 6)
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ferring Pharmaceuticals

Collaborators

Ferring Arzneimittel GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

June 21, 2010

First Submitted That Met QC Criteria

June 21, 2010

First Posted (Estimate)

June 22, 2010

Study Record Updates

Last Update Posted (Estimate)

December 22, 2011

Last Update Submitted That Met QC Criteria

December 21, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FE999303 CS01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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