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Quality of Life With TESTIM® (LIFE)

This study has been completed.
Sponsor:
Collaborator:
Ferring Arzneimittel GmbH
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01148433
First received: June 21, 2010
Last updated: December 21, 2011
Last verified: December 2011
History of Changes
  Purpose

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.


Condition
Hypogonadism

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Quality of Life With TESTIM® in Testosterone Replacement Therapy for Male Patients With Hypogonadism

Resource links provided by NLM:

MedlinePlus related topics: Fatigue
U.S. FDA Resources

Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Serum Testosterone Level [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Measured at Visit 1 (diagnosis), Visit 3 (month 3) and Visit 4 (month 6)


Secondary Outcome Measures:
  • Quality of Life - (determined by the MFI questionnaire) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Used at Visit 2 (month 0), Visit 3 (month 3) and Visit 4 (month 6)

  • Laboratory Parameters: PSA and Haematocrit levels [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Measured at Visit 1 (diagnosis), Visit 3 (month 3) and Visit 4 (month 6)


Enrollment: 157
Study Start Date: May 2010
Study Completion Date: July 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
TESTIM® - drug given by prescription
Male patients with Hypogonadism

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Private practices

Criteria

Inclusion Criteria:

  • therapeutic need according to SPC
  • written informed consent

Exclusion Criteria:

  • contraindications according to SPC
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01148433

  Show 64 Study Locations
Sponsors and Collaborators
Ferring Pharmaceuticals
Ferring Arzneimittel GmbH
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01148433     History of Changes
Other Study ID Numbers: FE999303 CS01
Study First Received: June 21, 2010
Last Updated: December 21, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Testosterone
Androgens
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013