Use of Nebido® to Assess Tolerability and Treatment Outcomes in Daily Clinical Practice
Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Male; Hypogonadism
Intervention: Testosterone Undecanoate (Nebido, BAY86-5037) (Drug)
Phase: N/A
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s): Bayer Study Director, Study Director, Affiliation: Bayer
Summary
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.
Clinical Details
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)
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Adverse events, adverse drug reactions, patient reported tolerability
Secondary outcome: Change in laboratory values (total testosterone, estradiol, SHGB, FSH, LH) from baseline to end of observationChange in subjective assessment of the patient (overall sexual desire/libido, vigor/vitality, mood, ability to concentrate) from baseline to end of observation Change in intensity of symptoms or disorders associated with low testosterone (hot flushes or excessive sweating, sleep disturbances, decreased physical strength and erectile dysfunction) from baseline to end of observation Patient reported outcome at end of observation (satisfaction with current androgen therapy, comparison to previous androgen therapy, if applicable) Treatment continuation rate Vital signs and anthropometric measurements (Blood pressure, heart rate, weight and waist circumference) Laboratory values (PSA, hemoglobin, hematocrit, HbA1C, T-chol, HDL-chol, LDL-chol, triglycerides) Digital rectal examination
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
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
Locations and Contacts
Many Locations, Australia
Many Locations, Austria
Many Locations, Bulgaria
Many Locations, Colombia
Many Locations, Czech Republic
Many Locations, Estonia
Many Locations, Germany
Many Locations, Hong Kong
Many Locations, Indonesia
Many Locations, Italy
Many Locations, Jordan
Many Locations, Kazakhstan
Many Locations, Korea, Republic of
Many Locations, Latvia
Many Locations, Lebanon
Many Locations, Lithuania
Many Locations, Macedonia, The Former Yugoslav Republic of
Many Locations, Malaysia
Many Locations, Malta
Many Locations, Mexico
Many Locations, Moldova, Republic of
Many Locations, Philippines
Many Locations, Romania
Many Locations, Russian Federation
Many Locations, Saudi Arabia
Many Locations, Singapore
Many Locations, Slovenia
Many Locations, Spain
Many Locations, Taiwan
Many Locations, Thailand
Many Locations, Turkey
Many Locations, Ukraine
Many Locations, United Kingdom
Additional Information
Click here and search for drug information provided by the FDA. Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.
Starting date: October 2006
Last updated: September 23, 2010
|