Safety of Testosterone Undecanoate i.m. in Hypogonadal Men
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.
Drug: Testosterone Substitution by Testosterone Undecanoate i.m.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Long-Term Intervention Phase 2 Study of Safety Aspects of Testosterone Undecanoate i.m. in Hypogonadal Men|
- Prostate (size, PSA-level)
- Erythropoeisis (Hemoglobin, Hematocrit)
- Lipoproteins (HDL, LDL, Triglycerides)
- Blood pressure
- Possible changes of body mass index
|Study Start Date:||April 1997|
|Study Completion Date:||January 2007|
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.
|Institute of Reproductive Medicine of the University Clinics|
|Study Director:||Eberhard Nieschlag, MD, PhD||University Clinics Muenster, Germany|