Safety of Testosterone Undecanoate i.m. in Hypogonadal Men
Information source: University Hospital Muenster
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypogonadism
Intervention: Testosterone Substitution by Testosterone Undecanoate i.m. (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: University Hospital Muenster Official(s) and/or principal investigator(s):
Eberhard Nieschlag, MD, PhD, Study Director, Affiliation: University Clinics Muenster, Germany
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.
Clinical Details
Official title: Long-Term Intervention Phase 2 Study of Safety Aspects of Testosterone Undecanoate i.m. in Hypogonadal Men
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Primary outcome: Prostate (size, PSA-level)Erythropoeisis (Hemoglobin, Hematocrit) Lipoproteins (HDL, LDL, Triglycerides) Blood pressure Pulse
Secondary outcome: Possible changes of body mass index
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.
Eligibility
Minimum age: 17 Years.
Maximum age: 70 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- Prostate Cancer
- Breast Cancer
- Desired Paternity
Locations and Contacts
Institute of Reproductive Medicine of the University Clinics, Muenster, Germany
Additional Information
Starting date: April 1997
Ending date: January 2007
Last updated: March 26, 2007
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