Quality of Life With TESTIM®

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01148433

Acronym

LIFE

Enrollment

157

Registered

2010-06-22

Start date

2010-05-31

Completion date

2011-07-31

Last updated

2011-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypogonadism

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* therapeutic need according to SPC * written informed consent

Exclusion criteria

* contraindications according to SPC

Design outcomes

Primary

Measure	Time frame	Description
Serum Testosterone Level	6 months	Measured at Visit 1 (diagnosis), Visit 3 (month 3) and Visit 4 (month 6)

Secondary

Measure	Time frame	Description
Quality of Life - (determined by the MFI questionnaire)	6 months	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)	6 months	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)	6 months	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)	6 months	Used at Visit 2 (month 0), Visit 3 (month 3) and Visit 4 (month 6)
Laboratory Parameters: PSA and Haematocrit levels	6 months	Measured at Visit 1 (diagnosis), Visit 3 (month 3) and Visit 4 (month 6)

Countries

Germany

Outcome results