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


Tracking Information

Start Date  ICMJEOctober 2006
Estimated Primary Completion DateJune 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: August 31, 2009)		Adverse events, adverse drug reactions, patient reported tolerability [ Time Frame: during 4 injection intervals ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures  ICMJE 
 (submitted: November 3, 2008)		Adverse events, adverse drug reactions, patient reported tolerability [ Time Frame: during 4 injection intervals ] [ Designated as safety issue: Yes ]
Change HistoryComplete list of historical versions of study NCT00410306 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as safety issue: No ]
  • Treatment continuation rate [ Time Frame: after 4 injection intervals ] [ Designated as safety issue: No ]
  • Vital signs and anthropometric measurements (Blood pressure, heart rate, weight and waist circumference) [ Time Frame: during 4 injection intervals ] [ Designated as safety issue: Yes ]
  • Laboratory values (PSA, hemoglobin, hematocrit, HbA1C, T-chol, HDL-chol, LDL-chol, triglycerides) [ Time Frame: during 4 injection intervals ] [ Designated as safety issue: Yes ]
  • Digital rectal examination [ Time Frame: during 4 injection intervals ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures  ICMJE 
 (submitted: November 3, 2008)
  • Change in laboratory values (total testosterone, estradiol, SHGB, FSH, LH) from baseline to end of observation [ Time Frame: after 4 injection intervals ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as safety issue: No ]
  • Treatment continuation rate [ Time Frame: after 4 injection intervals ] [ Designated as safety issue: No ]
  • Vital signs and anthropometric measurements (Blood pressure, heart rate, weight and waist circumference) [ Time Frame: during 4 injection intervals ] [ Designated as safety issue: Yes ]
  • Laboratory values (PSA, hemoglobin, hematocrit, HbA1C, T-chol, HDL-chol, LDL-chol, triglycerides) [ Time Frame: during 4 injection intervals ] [ Designated as safety issue: Yes ]
  • Digital rectal examination [ Time Frame: during 4 injection intervals ] [ Designated as safety issue: Yes ]

Descriptive Information

Brief Title  ICMJEUse of Nebido® to Assess Tolerability and Treatment Outcomes in Daily Clinical Practice
Official Title  ICMJEInternational, 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 Phase 
Study Type  ICMJEObservational
Study Design  ICMJECohort, Prospective
Condition  ICMJE
  • Male
  • Hypogonadism
Intervention  ICMJEDrug: Testosterone Undecanoate (Nebido, BAY86-5037)
Patients from routine practice
Study Arms / Comparison GroupsGroup 1
Intervention: Drug: Testosterone Undecanoate (Nebido, BAY86-5037)

Recruitment Information

Estimated Enrollment  ICMJE1500
Estimated Completion DateJune 2010
Estimated Primary Completion DateJune 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

GenderMale
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Bayer Clinical Trials Contactclinical-trials-contact@bayerhealthcare.com
Location Countries  ICMJEAustralia,   Austria,   Bosnia and Herzegovina,   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,   Mexico,   Moldova, Republic of,   Philippines,   Romania,   Russian Federation,   Saudi Arabia,   Singapore,   Slovenia,   Spain,   Taiwan,   Thailand,   Turkey,   Ukraine,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00410306
Responsible PartyMedical Affairs Therapeutic Area Head, Bayer Schering Pharma AG
Study ID Numbers  ICMJE14203, 2005/00888, MP-04199, NE0601
Study Sponsor  ICMJEBayer
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Bayer Study DirectorBayer
Information Provided ByBayer