- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00452322
Safety of Testosterone Undecanoate i.m. in Hypogonadal Men
Long-Term Intervention Phase 2 Study of Safety Aspects of Testosterone Undecanoate i.m. in Hypogonadal Men
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Muenster, Germany
- Institute of Reproductive Medicine of the University Clinics
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Blood pressure
|
Pulse
|
Prostate (size, PSA-level)
|
Erythropoeisis (Hemoglobin, Hematocrit)
|
Lipoproteins (HDL, LDL, Triglycerides)
|
Secondary Outcome Measures
Outcome Measure |
---|
Possible changes of body mass index
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Eberhard Nieschlag, MD, PhD, University Clinics Muenster, Germany
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Gonadal Disorders
- Hypogonadism
- Physiological Effects of Drugs
- Antineoplastic Agents
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Androgens
- Anabolic Agents
- Testosterone
- Methyltestosterone
- Testosterone undecanoate
- Testosterone enanthate
- Testosterone 17 beta-cypionate
Other Study ID Numbers
- IRM 96/17
- EK 78a/97Nie1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypogonadism
-
Rigshospitalet, DenmarkTerminatedHypogonadotropic Hypogonadism | Hypogonadism | Hypogonadism, MaleDenmark
-
Shanghai Jiao Tong University School of MedicineUnknownIdiopathic Hypogonadotropic Hypogonadism
-
Endo PharmaceuticalsCompletedHypogonadotropic Hypogonadism | Hypogonadism | Hypogonadism, MaleUnited States
-
Clarus Therapeutics, Inc.CompletedMale Hypogonadism | Secondary Hypogonadism | Primary HypogonadismUnited States
-
Amneal Pharmaceuticals, LLCPhase One Solutions, Inc.CompletedHypogonadotropic Hypogonadism | Primary HypogonadismUnited States
-
Endo PharmaceuticalsCompletedHypogonadism | Secondary Hypogonadism | Primary HypogonadismUnited States
-
Repros Therapeutics Inc.CompletedObesity | Acquired Hypogonadotropic HypogonadismUnited States
-
Massachusetts General HospitalRecruiting
-
Mereo BioPharmaCompleted
-
Organon and CoCompleted
Clinical Trials on Testosterone Substitution by Testosterone Undecanoate i.m.
-
Clarus Therapeutics, Inc.Completed
-
Endo PharmaceuticalsCompletedHypogonadism | Secondary Hypogonadism | Primary HypogonadismUnited States
-
Sports Medicine Research and Testing LaboratoryEnrolling by invitation
-
Clarus Therapeutics, Inc.Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterCompletedHypogonadismUnited States
-
Morten Hostrup, PhDNot yet recruitingSkeletal Muscle Physiology
-
Hospital de Niños R. Gutierrez de Buenos AiresNational Agency for Scientific and Technological Promotion, ArgentinaRecruitingMale Hypogonadism | Delayed PubertyArgentina
-
Clarus Therapeutics, Inc.CompletedMale HypogonadismUnited States, Germany
-
University of AdelaideOrganonUnknownMalnutrition | AgingAustralia
-
Fundación Pública Andaluza para la Investigación...Completed
-
Clarus Therapeutics, Inc.CelerionCompletedHypogonadismUnited States