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
  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:


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
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, see Learn About Clinical Studies.

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 August 28, 2014