Hypogonadism Clinical Trial
Official title:
Long-Term Intervention Phase 2 Study of Safety Aspects 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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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