Safety of Testosterone Undecanoate i.m. in Hypogonadal Men - Full Text View

Sponsor:	University Hospital Muenster
Information provided by:	University Hospital Muenster
ClinicalTrials.gov Identifier:	NCT00452322

Purpose

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.

Condition	Intervention	Phase
Hypogonadism	Drug: Testosterone Substitution by Testosterone Undecanoate i.m.	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	Long-Term Intervention Phase 2 Study of Safety Aspects of Testosterone Undecanoate i.m. in Hypogonadal Men

Resource links provided by NLM:

Drug Information available for: Testosterone Propionate Methyltestosterone Testosterone Oxymesterone Testosterone enanthate Testosterone undecanoate

U.S. FDA Resources

Further study details as provided by University Hospital Muenster:

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

Estimated Enrollment:	60
Study Start Date:	April 1997
Study Completion Date:	January 2007

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

Ages Eligible for Study:	17 Years to 70 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00452322

Locations

Germany
Institute of Reproductive Medicine of the University Clinics
Muenster, Germany

Sponsors and Collaborators

University Hospital Muenster

Investigators

Study Director:

Eberhard Nieschlag, MD, PhD

University Clinics Muenster, Germany

More Information

No publications provided by University Hospital Muenster

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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. Epub 2007 Jul 17.

Study ID Numbers:	IRM 96/17, EK 78a/97Nie1
Study First Received:	March 26, 2007
Last Updated:	March 26, 2007
ClinicalTrials.gov Identifier:	NCT00452322 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Muenster:

Testosterone
Hypogonadism
Safety

Additional relevant MeSH terms:

Antineoplastic Agents, Hormonal
Gonadal Disorders
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Endocrine System Diseases
Methyltestosterone
Hormones

Pharmacologic Actions
Testosterone 17 beta-cypionate
Anabolic Agents
Testosterone
Hypogonadism
Therapeutic Uses
Androgens

ClinicalTrials.gov processed this record on February 08, 2010