NCT00452322

Safety of Testosterone Undecanoate i.m. in Hypogonadal Men

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (planned)
• Sponsor: University Hospital Muenster · Academic / Other
• Sex: Male
• Age: 17 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Hypogonadism

Interventions

Type	Name	Description
DRUG	Testosterone Substitution by Testosterone Undecanoate i.m.

Timeline

• Start date: 1997-04-01
• Completion: 2007-01-01
• First posted: 2007-03-27
• Last updated: 2007-03-27

Locations

1 site across 1 country: Germany