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Sponsored by: |
Bayer |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00410306 |
This is an observational study with a drug called Nebido, a new testosterone replacement therapy, which is available for the treatment of male hypogonadism. The benefit and safety of Nebido have already been thoroughly evaluated through well controlled clinical trials.
The main purpose of this observational study is to confirm the established safety profile of Nebido in daily clinical practice.
Condition | Intervention |
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Male Hypogonadism |
Drug: Testosterone Undecanoate (Nebido, BAY86-5037) |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | International, Multi-Center Post Authorization Surveillance Study on the Use of Nebido® to Assess Tolerability and Treatment Outcomes in Daily Clinical Practice (IPASS Nebido) |
Estimated Enrollment: | 1500 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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Group 1 |
Drug: Testosterone Undecanoate (Nebido, BAY86-5037)
Patients from routine practice
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The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.
Bayer Schering Pharma AG, Germany is the sponsor of the trial.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
patients from routine practice
Inclusion Criteria:
Exclusion Criteria:
Contact: Bayer Clinical Trials Contact | clinical-trials-contact@bayerhealthcare.com |
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Bayer Schering Pharma AG ( Medical Affairs Therapeutic Area Head ) |
Study ID Numbers: | 14203, 2005/00888, MP-04199, NE0601, IPASS Nebido |
Study First Received: | December 11, 2006 |
Last Updated: | April 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00410306 History of Changes |
Health Authority: | Austria: Federal Ministry for Health and Women; Australia: Human Research Ethics Committee; Bulgaria: Bulgarian Drug Agency; Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos; Czech Republic: State Institute for Drug Control; Germany: Federal Institute for Drugs and Medical Devices; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Indonesia: National Agency of Drug and Food Control; Italy: Ethics Committee; Korea: Food and Drug Administration; Kazakhstan: National Center for Expertise of Medicinal Drugs; Macedonia: Ministry of Health; Malaysia: Ministry of Health; Philippines: Bureau of Food and Drugs; Romania: State Institute for Drug Control; Russia: Ministry of Health and Social Development of the Russian Federation; Singapore: Domain Specific Review Boards; Singapore: Health Sciences Authority; Thailand: Ethical Committee; Taiwan: Institutional Review Board; Ukraine: Ministry of Health |
Hypogonadism Nebido Testosterone Observational Study |
Antineoplastic Agents, Hormonal Gonadal Disorders Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Endocrine System Diseases Methyltestosterone Hormones |
Testosterone 17 beta-cypionate Testosterone Anabolic Agents Hypogonadism Endocrinopathy Androgens |
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 |