Status:
COMPLETED
Safety of Testosterone Undecanoate i.m. in Hypogonadal Men
Lead Sponsor:
University Hospital Muenster
Conditions:
Hypogonadism
Eligibility:
MALE
17-70 years
Phase:
PHASE2
Brief 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 testos...
Eligibility Criteria
Inclusion
- Men presenting hypogonadism-related symptoms and desiring substitution therapy. Such symptoms are fatigue, loss of libido, depressiveness, change in body composition/weight, decreased physical performance, decrease in aggressive behaviour, disability to cope, decreased work performance, lack of androgenization. At least one of these symptoms has to be accompanied by low total testosterone levels (\< 12 nmol / L).
- All patients have to give written informed consent for the use of their data for scientific evaluation as approved by the Ethics Committee of the Medical Faculty, University of Muenster, Germany and the State Medical Board.
Exclusion
- Prostate Cancer
- Breast Cancer
- Desired Paternity
Key Trial Info
Start Date :
April 1 1997
Trial Type :
INTERVENTIONAL
End Date :
January 1 2007
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00452322
Start Date
April 1 1997
End Date
January 1 2007
Last Update
March 27 2007
Active Locations (1)
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1
Institute of Reproductive Medicine of the University Clinics
Münster, Germany