Clinical trial NCT00410306: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Male
Hypogonadism
Keywords: Hypogonadism
Nebido
Testosterone
Observational Study
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2006-12-12
Enrollment: 1493
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from routine practice

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.

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

Primary outcomes:
measure: Adverse events, adverse drug reactions, patient reported tolerability
timeFrame: during 4 injection intervals
Secondary outcomes:
measure: Change in laboratory values (total testosterone, estradiol, SHGB, FSH, LH) from baseline to end of observation
timeFrame: after 4 injection intervals
measure: Change in subjective assessment of the patient (overall sexual desire/libido, vigor/vitality, mood, ability to concentrate) from baseline to end of observation
timeFrame: after 4 injection intervals
measure: 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
timeFrame: after 4 injection intervals
measure: Patient reported outcome at end of observation (satisfaction with current androgen therapy, comparison to previous androgen therapy, if applicable)
timeFrame: after 4 injection intervals
measure: Treatment continuation rate
timeFrame: after 4 injection intervals
measure: Vital signs and anthropometric measurements (Blood pressure, heart rate, weight and waist circumference)
timeFrame: during 4 injection intervals
measure: Laboratory values (PSA, hemoglobin, hematocrit, HbA1C, T-chol, HDL-chol, LDL-chol, triglycerides)
timeFrame: during 4 injection intervals
measure: Digital rectal examination
timeFrame: during 4 injection intervals
Other outcomes:
Locations:
city: Many Locations
country: Australia
city: Many Locations
country: Austria
city: Many Locations
country: Bulgaria
city: Many Locations
country: Colombia
city: Many Locations
country: Czech Republic
city: Many Locations
country: Estonia
city: Many Locations
country: Germany
city: Many Locations
country: Hong Kong
city: Many Locations
country: Indonesia
city: Many Locations
country: Italy
city: Many Locations
country: Jordan
city: Many Locations
country: Kazakhstan
city: Many Locations
country: Korea, Republic of
city: Many Locations
country: Latvia
city: Many Locations
country: Lebanon
city: Many Locations
country: Lithuania
city: Many Locations
country: Macedonia, The Former Yugoslav Republic of
city: Many Locations
country: Malaysia
city: Many Locations
country: Malta
city: Many Locations
country: Mexico
city: Many Locations
country: Moldova, Republic of
city: Many Locations
country: Philippines
city: Many Locations
country: Romania
city: Many Locations
country: Russian Federation
city: Many Locations
country: Saudi Arabia
city: Many Locations
country: Singapore
city: Many Locations
country: Slovenia
city: Many Locations
country: Spain
city: Many Locations
country: Taiwan
city: Many Locations
country: Thailand
city: Many Locations
country: Turkey
city: Many Locations
country: Ukraine
city: Many Locations
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: