Safety of Testosterone Undecanoate i.m. in Hypogonadal Men

Study Overview
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Brief Summary
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Treatment of male hypogonadism by testosterone substitution has be monitored in terms of safety. This study relates to safety of a new long-acting preparation.

Detailed Description
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A reliable form of androgen substitution therapy regarding kinetics, tolerance and restoration of androgenicity is paramount in hypogonadal men. Intramuscular injection of the long-acting ester testosterone undecanoate (TU) offers a new modality. The objective is to assess safety of TU regarding metabolic and pharmacogenetic confounders in hypogonadal men treated with this new formulation. This is a longitudinal prospective one-arm open intervention and observation trial. A minimum of 5 individual assessments is a prerequisite. Investigated modulators of safety parameters entering regression models are: nadir and/or delta total testosterone concentrations, body mass index (BMI), and age. The setting Andrological outpatient department.

Official Title
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Long-Term Intervention Phase 2 Study of Safety Aspects of Testosterone Undecanoate i.m. in Hypogonadal Men

Conditions
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Hypogonadism

Intervention / Treatment
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* Drug: Testosterone Substitution by Testosterone Undecanoate i.m.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men presenting hypogonadism-related symptoms and desiring substitution therapy. Such symptoms are fatigue, loss of libido, depressiveness, change in body composition/weight, decreased physical performance, decrease in aggressive behaviour, disability to cope, decreased work performance, lack of androgenization. At least one of these symptoms has to be accompanied by low total testosterone levels (< 12 nmol / L). All patients have to give written informed consent for the use of their data for scientific evaluation as approved by the Ethics Committee of the Medical Faculty, University of Muenster, Germany and the State Medical Board. Exclusion Criteria: Prostate Cancer Breast Cancer Desired Paternity

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Testosterone Substitution by Testosterone Undecanoate i.m.|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prostate (size, PSA-level) |  |  | 
| Erythropoeisis (Hemoglobin, Hematocrit) |  |  | 
| Lipoproteins (HDL, LDL, Triglycerides) |  |  | 
| Blood pressure |  |  | 
| Pulse |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Possible changes of body mass index |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Testosterone, Hypogonadism, Safety