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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00410306
Recruitment Status : Completed
First Posted : December 12, 2006
Last Update Posted : September 24, 2010
Sponsor:
Information provided by:
Bayer

Tracking Information
First Submitted Date December 11, 2006
First Posted Date December 12, 2006
Last Update Posted Date September 24, 2010
Study Start Date October 2006
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 31, 2009)
Adverse events, adverse drug reactions, patient reported tolerability [ Time Frame: during 4 injection intervals ]
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00410306 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 31, 2009)
  • Change in laboratory values (total testosterone, estradiol, SHGB, FSH, LH) from baseline to end of observation [ Time Frame: after 4 injection intervals ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Treatment continuation rate [ Time Frame: after 4 injection intervals ]
  • Vital signs and anthropometric measurements (Blood pressure, heart rate, weight and waist circumference) [ Time Frame: during 4 injection intervals ]
  • Laboratory values (PSA, hemoglobin, hematocrit, HbA1C, T-chol, HDL-chol, LDL-chol, triglycerides) [ Time Frame: during 4 injection intervals ]
  • Digital rectal examination [ Time Frame: during 4 injection intervals ]
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Use of Nebido® to Assess Tolerability and Treatment Outcomes 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)
Brief 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.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients from routine practice
Condition
  • Male
  • Hypogonadism
Intervention Drug: Testosterone Undecanoate (Nebido, BAY86-5037)
Patients from routine practice
Study Groups/Cohorts Group 1
Intervention: Drug: Testosterone Undecanoate (Nebido, BAY86-5037)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 23, 2010)
1493
Original Enrollment Not Provided
Actual Study Completion Date July 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Mexico,   Australia,   Austria,   Bulgaria,   Colombia,   Czech Republic,   Estonia,   Germany,   Hong Kong,   Indonesia,   Italy,   Jordan,   Kazakhstan,   Korea, Republic of,   Latvia,   Lebanon,   Lithuania,   Macedonia, The Former Yugoslav Republic of,   Malaysia,   Malta,   Moldova, Republic of,   Philippines,   Romania,   Russian Federation,   Saudi Arabia,   Singapore,   Slovenia,   Spain,   Taiwan,   Thailand,   Turkey,   Ukraine,   United Kingdom
Removed Location Countries Bosnia and Herzegovina,   China
 
Administrative Information
NCT Number NCT00410306
Other Study ID Numbers 14203
2005/00888
MP-04199
NE0601
39732
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Medical Affairs Therapeutic Area Head, Bayer Schering Pharma AG
Study Sponsor Bayer
Collaborators Not Provided
Investigators
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date September 2010