Use of Nebido® to Assess Tolerability and Treatment Outcomes in Daily Clinical Practice

Condition(s) targeted: Male; Hypogonadism

Intervention: Testosterone Undecanoate (Nebido, BAY86-5037) (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Overall contact:
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

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.

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: Cohort, 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.

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

Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

Many Locations, Australia; Recruiting

Many Locations, Austria; Recruiting

Many Locations, Bosnia and Herzegovina; Not yet recruiting

Many Locations, Bulgaria; Recruiting

Many Locations, Colombia; Recruiting

Many Locations, Czech Republic; Recruiting

Many Locations, Estonia; Terminated

Many Locations, Germany; Recruiting

Many Locations, Hong Kong; Recruiting

Many Locations, Indonesia; Recruiting

Many Locations, Italy; Recruiting

Many Locations, Jordan; Terminated

Many Locations, Kazakhstan; Recruiting

Many Locations, Korea, Republic of; Recruiting

Many Locations, Latvia; Terminated

Many Locations, Lebanon; Terminated

Many Locations, Lithuania; Terminated

Many Locations, Macedonia, The Former Yugoslav Republic of; Recruiting

Many Locations, Malaysia; Recruiting

Many Locations, Malta; Terminated

Many Locations, Mexico; Recruiting

Many Locations, Moldova, Republic of; Recruiting

Many Locations, Philippines; Recruiting

Many Locations, Romania; Recruiting

Many Locations, Russian Federation; Recruiting

Many Locations, Saudi Arabia; Recruiting

Many Locations, Singapore; Recruiting

Many Locations, Slovenia; Terminated

Many Locations, Spain; Terminated

Many Locations, Taiwan; Recruiting

Many Locations, Thailand; Recruiting

Many Locations, Turkey; Terminated

Many Locations, Ukraine; Not yet recruiting

Many Locations, United Kingdom; Recruiting

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Starting date: October 2006
Ending date: June 2010
Last updated: October 1, 2009