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Completed

NCT Number: NCT01148433

Quality of Life With TESTIM®

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.

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Key information

Conditions

Hypogonadism Endocrine System Diseases Gonadal Disorders

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Investigational Site, Apolda, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • therapeutic need according to SPC
  • written informed consent

Exclusion criteria

  • contraindications according to SPC

Treatment and study plan

Primary outcomes

  1. Serum Testosterone Level

    Time frame: 6 months

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

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. Laboratory Parameters: PSA and Haematocrit levels

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Collaborators

  • Ferring Arzneimittel GmbH

Registry information

Official study title

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

Acronym: LIFE

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 22, 2010
Registry last updated
Dec 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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