Safety of Testosterone Undecanoate i.m. in Hypogonadal Men
|ClinicalTrials.gov Identifier: NCT00452322|
Recruitment Status : Completed
First Posted : March 27, 2007
Last Update Posted : March 27, 2007
|Condition or disease||Intervention/treatment||Phase|
|Hypogonadism||Drug: Testosterone Substitution by Testosterone Undecanoate i.m.||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Long-Term Intervention Phase 2 Study of Safety Aspects of Testosterone Undecanoate i.m. in Hypogonadal Men|
|Study Start Date :||April 1997|
|Study Completion Date :||January 2007|
- Prostate (size, PSA-level)
- Erythropoeisis (Hemoglobin, Hematocrit)
- Lipoproteins (HDL, LDL, Triglycerides)
- Blood pressure
- Possible changes of body mass index
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00452322
|Institute of Reproductive Medicine of the University Clinics|
|Study Director:||Eberhard Nieschlag, MD, PhD||University Clinics Muenster, Germany|