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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
TESTIM® - drug given by prescription
Male patients with Hypogonadism

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ferring Pharmaceuticals

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 21, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 22, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 22, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings