ClinicalTrials.gov
ClinicalTrials.gov Menu

Quality of Life With TESTIM® (LIFE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01148433
Recruitment Status : Completed
First Posted : June 22, 2010
Last Update Posted : December 22, 2011
Sponsor:
Collaborator:
Ferring Arzneimittel GmbH
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Brief 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). 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 or disease
Hypogonadism

Study Type : Observational
Actual Enrollment : 157 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Quality of Life With TESTIM® in Testosterone Replacement Therapy for Male Patients With Hypogonadism
Study Start Date : May 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : July 2011


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



Primary Outcome Measures :
  1. Serum Testosterone Level [ Time Frame: 6 months ]
    Measured at Visit 1 (diagnosis), Visit 3 (month 3) and Visit 4 (month 6)


Secondary Outcome Measures :
  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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01148433


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

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01148433     History of Changes
Other Study ID Numbers: FE999303 CS01
First Posted: June 22, 2010    Key Record Dates
Last Update Posted: December 22, 2011
Last Verified: December 2011

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