Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Bayer |
---|---|
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 | Phase |
---|---|---|
Male Hypogonadism |
Drug: Testosterone Undecanoate |
Phase IV |
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 |
---|---|
Group 1 |
Drug: Testosterone Undecanoate
patients from routine practice
|
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:
- Male hypogonadal patients eligible for long-term testosterone therapy who have newly been prescribed Nebido® in accordance with the terms of the marketing authorization
Exclusion Criteria:
- Patients presenting with contraindications as stated in the product information
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: | January 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00410306 |
Health Authority: | Australia: Human Research Ethics Committee; Austria: Federal Ministry for Health and Women; 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; Indonesia: National Agency of Drug and Food Control; Italy: Ethics Committee; Korea: Food and Drug Administration; 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; Taiwan: Institutional Review Board; Thailand: Ethical Committee; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Ukraine: Ministry of Health; United States: Food and Drug Administration |
Hypogonadism Nebido Testosterone Observational Study |
Testosterone Hypogonadism Gonadal Disorders Endocrine System Diseases |
Methyltestosterone Endocrinopathy Testosterone 17 beta-cypionate |
Anabolic Agents Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs |
Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Pharmacologic Actions Androgens |