NCT00452322

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 1997

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1997

Completed
9.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 27, 2007

Completed
Last Updated

March 27, 2007

Status Verified

March 1, 2007

First QC Date

March 26, 2007

Last Update Submit

March 26, 2007

Conditions

Hypogonadism

Keywords

TestosteroneHypogonadismSafety

Outcome Measures

Primary Outcomes (5)

  • Prostate (size, PSA-level)

  • Erythropoeisis (Hemoglobin, Hematocrit)

  • Lipoproteins (HDL, LDL, Triglycerides)

  • Blood pressure

  • Pulse

Secondary Outcomes (1)

  • Possible changes of body mass index

Interventions

Testosterone Substitution by Testosterone Undecanoate i.m.DRUG

Eligibility Criteria

Age17 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Prostate Cancer
  • Breast Cancer
  • Desired Paternity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Reproductive Medicine of the University Clinics

Münster, Germany

Location

Related Publications (1)

  • 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.

    PMID: 17635942DERIVED

MeSH Terms

Conditions

Hypogonadism

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System Diseases

Study Officials

  • Eberhard Nieschlag, MD, PhD

    University Clinics Muenster, Germany

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 26, 2007

First Posted

March 27, 2007

Study Start

April 1, 1997

Study Completion

January 1, 2007

Last Updated

March 27, 2007

Record last verified: 2007-03

Locations

DE(1)