check_circleStudy Completed

Male, Hypogonadism

Bayer Identifier:

14203

ClinicalTrials.gov Identifier:

NCT00410306

EudraCT Number:

Not Available

EU CT Number:

Not Available
Use of Nebido® to assess tolerability and treatment outcomes in daily clinical practice

Trial purpose

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.

Key Participants Requirements

Sex

Male

Age

18 - N/A
  • - Male hypogonadal patients eligible for long-term testosterone therapy who have newly been prescribed Nebido® in accordance with the terms of the marketing authorization
  • - Patients presenting with contraindications as stated in the product information

Trial summary

Enrollment Goal
1493
Trial Dates
October 2006 - July 2010
Phase
N/A
Could I Receive a placebo
No
Products
Nebido (Testosterone Undeconate, BAY86-5037)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Italy
Terminated
Many Locations, Lithuania
Completed
Many Locations, Hong Kong
Completed
Many Locations, Malaysia
Completed
Many Locations, Philippines
Completed
Many Locations, Thailand
Completed
Many Locations, Saudi Arabia
Completed
Many Locations, Moldova
Terminated
Many Locations, Jordan
Terminated
Many Locations, Lebanon
Terminated
Many Locations, Malta
Completed
Many Locations, Germany
Completed
Many Locations, United Kingdom
Terminated
Many Locations, Spain
Terminated
Many Locations, Mexico
Completed
Many Locations, Czech Republic
Completed
Many Locations, Australia
Completed
Many Locations, Bulgaria
Completed
Many Locations, Austria
Terminated
Many Locations, Turkey
Completed
Many Locations, Colombia
Completed
Many Locations, Russia
Completed
Many Locations, Ukraine
Completed
Many Locations, Indonesia
Completed
Many Locations, Korea, Republic Of
Completed
Many Locations, Taiwan
Terminated
Many Locations, Estonia
Completed
Many Locations, Singapore
Terminated
Many Locations, Latvia
Terminated
Many Locations, Slovenia
Completed
Many Locations, Romania
Completed
Many Locations, Kazakhstan
Completed
Many Locations, Macedonia
Terminated
Many Locations, Malta

Primary Outcome

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

Secondary Outcome

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

Trial design

International, multi-center post authorization surveillance study on the use of Nebido® to assess tolerability and treatment outcomes in daily clinical practice (IPASS Nebido)
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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