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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00410306




Registration number
NCT00410306
Ethics application status
Date submitted
11/12/2006
Date registered
12/12/2006
Date last updated
24/09/2010

Titles & IDs
Public title
Use of Nebido® to Assess Tolerability and Treatment Outcomes in Daily Clinical Practice
Scientific 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)
Secondary ID [1] 0 0
2005/00888
Secondary ID [2] 0 0
14203
Universal Trial Number (UTN)
Trial acronym
IPASS Nebido
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Male 0 0
Hypogonadism 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - Testosterone Undecanoate (Nebido, BAY86-5037)

Group 1 -


Treatment: Drugs: Testosterone Undecanoate (Nebido, BAY86-5037)
Patients from routine practice
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse events, adverse drug reactions, patient reported tolerability
Timepoint [1] 0 0
during 4 injection intervals
Secondary outcome [1] 0 0
Change in laboratory values (total testosterone, estradiol, SHGB, FSH, LH) from baseline to end of observation
Timepoint [1] 0 0
after 4 injection intervals
Secondary outcome [2] 0 0
Change in subjective assessment of the patient (overall sexual desire/libido, vigor/vitality, mood, ability to concentrate) from baseline to end of observation
Timepoint [2] 0 0
after 4 injection intervals
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
after 4 injection intervals
Secondary outcome [4] 0 0
Patient reported outcome at end of observation (satisfaction with current androgen therapy, comparison to previous androgen therapy, if applicable)
Timepoint [4] 0 0
after 4 injection intervals
Secondary outcome [5] 0 0
Treatment continuation rate
Timepoint [5] 0 0
after 4 injection intervals
Secondary outcome [6] 0 0
Vital signs and anthropometric measurements (Blood pressure, heart rate, weight and waist circumference)
Timepoint [6] 0 0
during 4 injection intervals
Secondary outcome [7] 0 0
Laboratory values (PSA, hemoglobin, hematocrit, HbA1C, T-chol, HDL-chol, LDL-chol, triglycerides)
Timepoint [7] 0 0
during 4 injection intervals
Secondary outcome [8] 0 0
Digital rectal examination
Timepoint [8] 0 0
during 4 injection intervals

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients presenting with contraindications as stated in the product information

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2010
Sample size
Target
Accrual to date
Final
1493
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Many Locations
Recruitment postcode(s) [1] 0 0
- Many Locations
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Many Locations
Country [2] 0 0
Bulgaria
State/province [2] 0 0
Many Locations
Country [3] 0 0
Colombia
State/province [3] 0 0
Many Locations
Country [4] 0 0
Czech Republic
State/province [4] 0 0
Many Locations
Country [5] 0 0
Estonia
State/province [5] 0 0
Many Locations
Country [6] 0 0
Germany
State/province [6] 0 0
Many Locations
Country [7] 0 0
Hong Kong
State/province [7] 0 0
Many Locations
Country [8] 0 0
Indonesia
State/province [8] 0 0
Many Locations
Country [9] 0 0
Italy
State/province [9] 0 0
Many Locations
Country [10] 0 0
Jordan
State/province [10] 0 0
Many Locations
Country [11] 0 0
Kazakhstan
State/province [11] 0 0
Many Locations
Country [12] 0 0
Korea, Republic of
State/province [12] 0 0
Many Locations
Country [13] 0 0
Latvia
State/province [13] 0 0
Many Locations
Country [14] 0 0
Lebanon
State/province [14] 0 0
Many Locations
Country [15] 0 0
Lithuania
State/province [15] 0 0
Many Locations
Country [16] 0 0
Macedonia, The Former Yugoslav Republic of
State/province [16] 0 0
Many Locations
Country [17] 0 0
Malaysia
State/province [17] 0 0
Many Locations
Country [18] 0 0
Malta
State/province [18] 0 0
Many Locations
Country [19] 0 0
Mexico
State/province [19] 0 0
Many Locations
Country [20] 0 0
Moldova, Republic of
State/province [20] 0 0
Many Locations
Country [21] 0 0
Philippines
State/province [21] 0 0
Many Locations
Country [22] 0 0
Romania
State/province [22] 0 0
Many Locations
Country [23] 0 0
Russian Federation
State/province [23] 0 0
Many Locations
Country [24] 0 0
Saudi Arabia
State/province [24] 0 0
Many Locations
Country [25] 0 0
Singapore
State/province [25] 0 0
Many Locations
Country [26] 0 0
Slovenia
State/province [26] 0 0
Many Locations
Country [27] 0 0
Spain
State/province [27] 0 0
Many Locations
Country [28] 0 0
Taiwan
State/province [28] 0 0
Many Locations
Country [29] 0 0
Thailand
State/province [29] 0 0
Many Locations
Country [30] 0 0
Turkey
State/province [30] 0 0
Many Locations
Country [31] 0 0
Ukraine
State/province [31] 0 0
Many Locations
Country [32] 0 0
United Kingdom
State/province [32] 0 0
Many Locations

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00410306
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00410306