Safety of Testosterone Undecanoate i.m. in Hypogonadal Men

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-04-30

Study Completion Date

2007-01-31

Brief Summary

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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

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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.

Conditions

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Hypogonadism

Keywords

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Testosterone Hypogonadism Safety

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Testosterone Substitution by Testosterone Undecanoate i.m.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

17 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Principal Investigators

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Eberhard Nieschlag, MD, PhD

Role: STUDY_DIRECTOR

University Clinics Muenster, Germany

Locations

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Institute of Reproductive Medicine of the University Clinics

Münster, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED

PMID: 17635942 (View on PubMed)

Other Identifiers

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EK 78a/97Nie1

Identifier Type: -

Identifier Source: secondary_id

IRM 96/17