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HypogonadismLIFENCT01148433

Quality of Life With TESTIM®

An observational study of Hypogonadism, run by Ferring Pharmaceuticals at 64 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Hypogonadism
How many people
157 participants
Where
64 sitesGermany
Study dates
May 2010to Jul 2011
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Study population: Private practices

Who may be able to join

  • therapeutic need according to SPC
  • written informed consent

Who cannot join

  • contraindications according to SPC

Trial locations and contacts

64 sites in 1 country.

64 sites in 1 country

Germany64 sites

  • Investigational Site

    Apolda

  • Investigational Site

    Aschersleben

  • Investigational Site

    Bad Bergzaben

  • Investigational Site

    Bad Schönborn

  • Investigational Site

    Bautzen

  • Investigational Site, Helene-Weigel-Platz 10

    Berlin

  • Investigational Site, Kurfürstendamm 33

    Berlin

  • Investigational Site, Königin-Elisabeth-Straße 1

    Berlin

  • Investigational Site, Tempelhofer Damm 227

    Berlin

  • Investigational Site, Turmstraße 82

    Berlin

  • Investigational Site, Wilmersdorfer Straße 62

    Berlin

  • Investigational site

    Bielefeld

  • Investigational Site

    Bramsche

  • Investigational Site, Humboldtstraße 4

    Braunschweig

  • Investigational site, Ritterbrunen 7

    Braunschweig

  • Investigational Site, Dr.-Franz-Mertens-Straße 8

    Bremerhaven

  • Investigational Site

    Bremerhaven

  • Investigational Site

    Büdingen

  • Investigational Site, Carl-von-Ossietzky-Straße 151

    Chemnitz

  • Investigational Site, Clausstraße 44

    Chemnitz

  • Investigational Site, Unritzstraße 21 c

    Chemnitz

  • Investigational Site

    Cologne

  • Investigational Site

    Dortmund

  • Investigational Site

    Dossenheim

  • Investigational Site

    Düsseldorf

  • Investigational Site

    Forchheim

  • Investigational Site, Eschersheimer Landstr. 544

    Frankfurt

  • Investigational Site, Im Steinbügel 13

    Frankfurt

  • Investigational Site

    Freiberg

  • Investigational Site

    Fulda

  • Investigational site

    Gera

  • Investigational Site

    Greifswald

  • Investigational Site

    Halle

  • Investigational Site, Neuenfelder Straße 96

    Hamburg

  • Investigational Site, Sand 35

    Hamburg

  • Investigational Site, Schweriner Straße 25

    Hamburg

  • Investigational Site, Tangstedter Landstraße 77

    Hamburg

  • Investigational Site

    Heilbronn

  • Investigational Site

    Henningsdorf

  • Investigational Site

    Hermsdorf

  • Investigational Site

    Kamenz

  • Investigational Site

    Kulmbach

  • Investigational Site

    Landsberg/Lech

  • Investigational Site

    Langenfeld

  • Investigational Site

    Lübeck

  • Investigational Site

    Mühlhausen

  • Investigational Site

    München

  • Investigational Site

    Neustadt

  • Investigational Site, Am Museumsturm 4

    Nordhorn

  • Investigational Site, Osnabrücker Str. 1

    Nordhorn

  • Investigational Site

    Nuremberg

  • Investigational Site

    Offenbach

  • Investigational Site

    Paderborn

  • Investigational Site

    Pulheim

  • Investigational Site

    Ribnitz-Damgarten

  • Investigational Site

    Rostock

  • Investigational Site

    Rottweil

  • Investigational Site

    Rüttenscheid

  • Investigational Site

    Schwerte

  • Investigational Site

    Tönisvorst

  • Investigational Site

    Tostedt

  • Investigational Site

    Weinheim

  • Investigational Site

    Wilhelmshaven

  • Investigational Site

    Wolfsburg

Other trials in Germany

About this study

Official title: 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.

Conditions
Hypogonadism
Medical subject headings
Hypogonadism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01148433
Study groupRoleWhat they receive
TESTIM® - drug given by prescriptionMale patients with Hypogonadism

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serum Testosterone Level

    Measured at Visit 1 (diagnosis), Visit 3 (month 3) and Visit 4 (month 6)

    Measured: 6 months

Secondary outcomes (5)

  1. Quality of Life - (determined by the MFI questionnaire)

    Determined at Visit 2 (month 0), Visit 3 (month 3) and Visit 4 (month 6)

    Measured: 6 months

  2. 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)

    Measured: 6 months

  3. 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)

    Measured: 6 months

  4. 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)

    Measured: 6 months

  5. Laboratory Parameters: PSA and Haematocrit levels

    Measured at Visit 1 (diagnosis), Visit 3 (month 3) and Visit 4 (month 6)

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2010 (estimated)
  2. Study startMay 2010
  3. Primary completionJun 2011
  4. Study completionJul 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
157 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01148433
Sponsor's protocol ID
FE999303 CS01
Acronym
LIFE
Status last verified
Dec 2011
First submitted
21 Jun 2010
Last updated
22 Dec 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Hypogonadism, run by Ferring Pharmaceuticals at 64 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 64 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum Testosterone Level (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01148433.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2011.

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