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

NCT00410306 | Completed

• 5 other identifiers: 142032005/00888MP-04199NE060139732
• Study Type: observational
• Target: 1,493
• Locations: 31 countries
• Sites: 31

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.

Conditions

Male; Hypogonadism

Keywords

Hypogonadism; Nebido; Testosterone; Observational Study

Outcome Measures

Primary Outcomes (1)

• Adverse events, adverse drug reactions, patient reported tolerability

  during 4 injection intervals

Secondary Outcomes (8)

• Change in laboratory values (total testosterone, estradiol, SHGB, FSH, LH) from baseline to end of observation

  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

  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

  after 4 injection intervals

• Patient reported outcome at end of observation (satisfaction with current androgen therapy, comparison to previous androgen therapy, if applicable)

  after 4 injection intervals

• Treatment continuation rate

  after 4 injection intervals

Study Arms (1)

Group 1

Drug: Testosterone Undecanoate (Nebido, BAY86-5037)

Interventions

Testosterone Undecanoate (Nebido, BAY86-5037) DRUG

Patients from routine practice

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from routine practice

You may qualify if:

• Male hypogonadal patients eligible for long-term testosterone therapy who have newly been prescribed Nebido® in accordance with the terms of the marketing authorization

You may not qualify if:

• Patients presenting with contraindications as stated in the product information

Sponsors & Collaborators

• Bayer: lead

Study Sites (33)

Unknown Facility

Many Locations, Australia

Location

Unknown Facility

Many Locations, Austria

Location

Unknown Facility

Many Locations, Bulgaria

Location

Unknown Facility

Many Locations, Colombia

Location

Unknown Facility

Many Locations, Czechia

Location

Unknown Facility

Many Locations, Estonia

Location

Unknown Facility

Many Locations, Germany

Location

Unknown Facility

Many Locations, Hong Kong

Location

Unknown Facility

Many Locations, Indonesia

Location

Unknown Facility

Many Locations, Italy

Location

Unknown Facility

Many Locations, Jordan

Location

Unknown Facility

Many Locations, Kazakhstan

Location

Unknown Facility

Many Locations, Latvia

Location

Unknown Facility

Many Locations, Lebanon

Location

Unknown Facility

Many Locations, Lithuania

Location

Unknown Facility

Many Locations, Malaysia

Location

Unknown Facility

Many Locations, Malta

Location

Unknown Facility

Many Locations, Mexico

Location

Unknown Facility

Many Locations, Moldova

Location

Unknown Facility

Many Locations, North Macedonia

Location

Unknown Facility

Many Locations, Philippines

Location

Unknown Facility

Many Locations, Romania

Location

Unknown Facility

Many Locations, Russia

Location

Unknown Facility

Many Locations, Saudi Arabia

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Unknown Facility

Many Locations, Singapore

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Unknown Facility

Many Locations, Slovenia

Location

Unknown Facility

Many Locations, South Korea

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Unknown Facility

Many Locations, Spain

Location

Unknown Facility

Many Locations, Taiwan

Location

Unknown Facility

Many Locations, Thailand

Location

Unknown Facility

Many Locations, Turkey (Türkiye)

Location

Unknown Facility

Many Locations, Ukraine

Location

Unknown Facility

Many Locations, United Kingdom

Location

MeSH Terms

Conditions

Hypogonadism

Interventions

testosterone undecanoate

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 11, 2006
• First Posted: December 12, 2006
• Study Start: October 1, 2006
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: September 24, 2010

Record last verified: 2010-09

Locations

SA (1); SG (1); TU (1); ME (1); LA (1); HK (1); RO (1); MO (1); RU (1); AU (1); IT (1); CO (1); CZ (1); MA (1); GB (1); UA (1); BU (1); SL (1); TW (1); TH (1); NO (1); JO (1); PH (1); LE (1); LI (1); DE (1); MY (1); ES (1); KR (1); KA (1); ID (1)