Safety of Testosterone Undecanoate i.m. in Hypogonadal Men
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|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)|
|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|
|Actual Study Completion Date :||January 2007|
- Prostate (size, PSA-level)
- Erythropoeisis (Hemoglobin, Hematocrit)
- Lipoproteins (HDL, LDL, Triglycerides)
- Blood pressure
- Possible changes of body mass index
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|