Safety of Testosterone Undecanoate i.m. in Hypogonadal Men
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Long-Term Intervention Phase 2 Study of Safety Aspects of Testosterone Undecanoate i.m. in Hypogonadal Men |
- Prostate (size, PSA-level)
- Erythropoeisis (Hemoglobin, Hematocrit)
- Lipoproteins (HDL, LDL, Triglycerides)
- Blood pressure
- Pulse
- Possible changes of body mass index
| Estimated Enrollment: | 60 |
| Study Start Date: | April 1997 |
| Study Completion Date: | January 2007 |
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 |
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| Germany | |
| Institute of Reproductive Medicine of the University Clinics | |
| Muenster, Germany | |
| 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 ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00452322 History of Changes |
| Other Study ID Numbers: | IRM 96/17, EK 78a/97Nie1 |
| Study First Received: | March 26, 2007 |
| Last Updated: | March 26, 2007 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by University Hospital Muenster:
|
Testosterone Hypogonadism Safety |
Additional relevant MeSH terms:
|
Hypogonadism Gonadal Disorders Endocrine System Diseases Testosterone Testosterone enanthate Testosterone undecanoate Testosterone 17 beta-cypionate Methyltestosterone Androgens |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Anabolic Agents |
ClinicalTrials.gov processed this record on May 16, 2013