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)”

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.

Study Type: Observational

Study Design: Observational Model: Cohort, Time Perspective: Prospective

Study Primary Completion Date: September 2010

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.

Intervention(s) in this Clinical Trial

• Drug: Testosterone Undecanoate (Nebido, BAY86-5037)
  • Patients from routine practice

Arms, Groups and Cohorts in this Clinical Trial

• : Group 1

Primary Measures

• Adverse events, adverse drug reactions, patient reported tolerability
  • Time Frame: during 4 injection intervals
    Safety Issue?: Yes

Secondary Measures

• Change in laboratory values (total testosterone, estradiol, SHGB, FSH, LH) from baseline to end of observation
  • Time Frame: after 4 injection intervals
    Safety Issue?: No
• Change in subjective assessment of the patient (overall sexual desire/libido, vigor/vitality, mood, ability to concentrate) from baseline to end of observation
  • Time Frame: after 4 injection intervals
    Safety Issue?: No
• 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
  • Time Frame: after 4 injection intervals
    Safety Issue?: No
• Patient reported outcome at end of observation (satisfaction with current androgen therapy, comparison to previous androgen therapy, if applicable)
  • Time Frame: after 4 injection intervals
    Safety Issue?: No
• Treatment continuation rate
  • Time Frame: after 4 injection intervals
    Safety Issue?: No
• Vital signs and anthropometric measurements (Blood pressure, heart rate, weight and waist circumference)
  • Time Frame: during 4 injection intervals
    Safety Issue?: Yes
• Laboratory values (PSA, hemoglobin, hematocrit, HbA1C, T-chol, HDL-chol, LDL-chol, triglycerides)
  • Time Frame: during 4 injection intervals
    Safety Issue?: Yes
• Digital rectal examination
  • Time Frame: during 4 injection intervals
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Bayer

Overall Clinical Trial Officials and Contacts

Bayer Study Director Study Director Bayer  

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

Information obtained from ClinicalTrials.gov on September 07, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00410306

Study ID Number: 14203

ClinicalTrials.gov Identifier: NCT00410306

Health Authority: Austria: Federal Ministry for Health and Women

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