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Safety of Testosterone Undecanoate i.m. in Hypogonadal Men

Primary Purpose

Hypogonadism

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Testosterone Substitution by Testosterone Undecanoate i.m.
Sponsored by
University Hospital Muenster
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypogonadism focused on measuring Testosterone, Hypogonadism, Safety

Eligibility Criteria

17 Years - 70 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Reproductive Medicine of the University Clinics

Outcomes

Primary Outcome Measures

Prostate (size, PSA-level)
Erythropoeisis (Hemoglobin, Hematocrit)
Lipoproteins (HDL, LDL, Triglycerides)
Blood pressure
Pulse

Secondary Outcome Measures

Possible changes of body mass index

Full Information

First Posted
March 26, 2007
Last Updated
March 26, 2007
Sponsor
University Hospital Muenster
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1. Study Identification

Unique Protocol Identification Number
NCT00452322
Brief Title
Safety of Testosterone Undecanoate i.m. in Hypogonadal Men
Official Title
Long-Term Intervention Phase 2 Study of Safety Aspects of Testosterone Undecanoate i.m. in Hypogonadal Men
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
April 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital Muenster

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadism
Keywords
Testosterone, Hypogonadism, Safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Testosterone Substitution by Testosterone Undecanoate i.m.
Primary Outcome Measure Information:
Title
Prostate (size, PSA-level)
Title
Erythropoeisis (Hemoglobin, Hematocrit)
Title
Lipoproteins (HDL, LDL, Triglycerides)
Title
Blood pressure
Title
Pulse
Secondary Outcome Measure Information:
Title
Possible changes of body mass index

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eberhard Nieschlag, MD, PhD
Organizational Affiliation
University Clinics Muenster, Germany
Official's Role
Study Director
Facility Information:
Facility Name
Institute of Reproductive Medicine of the University Clinics
City
Muenster
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
17635942
Citation
Zitzmann M, Nieschlag E. Androgen receptor gene CAG repeat length and body mass index modulate the safety of long-term intramuscular testosterone undecanoate therapy in hypogonadal men. J Clin Endocrinol Metab. 2007 Oct;92(10):3844-53. doi: 10.1210/jc.2007-0620. Epub 2007 Jul 17.
Results Reference
derived

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Safety of Testosterone Undecanoate i.m. in Hypogonadal Men

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