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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 observation

Change 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

Page last updated: August 23, 2015

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