Safety of Testosterone Undecanoate i.m. in Hypogonadal Men

Hypogonadism Clinical Trial

Official title:

Long-Term Intervention Phase 2 Study of Safety Aspects of Testosterone Undecanoate i.m. in Hypogonadal Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00452322
• Other study ID #: IRM 96/17
• Secondary ID: EK 78a/97Nie1
• Status: Completed
• Phase: Phase 2
• First received: March 26, 2007
• Last updated: March 26, 2007
• Start date: April 1997
• Est. completion date: January 2007

Study information

• Verified date: March 2007
• Source: University Hospital Muenster
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 17 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypogonadism

Intervention

Drug:
• Testosterone Substitution by Testosterone Undecanoate i.m.

Locations

Country	Name	City	State
Germany	Institute of Reproductive Medicine of the University Clinics	Muenster

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Muenster

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prostate (size, PSA-level)
Primary	Erythropoeisis (Hemoglobin, Hematocrit)
Primary	Lipoproteins (HDL, LDL, Triglycerides)
Primary	Blood pressure
Primary	Pulse
Secondary	Possible changes of body mass index