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Completed

NCT Number: NCT00410306

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

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.

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Key information

Conditions

Male Endocrine System Diseases Gonadal Disorders Hypogonadism

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Many Locations, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Testosterone Undecanoate (Nebido, BAY86-5037)

Drug

Patients from routine practice

Primary outcomes

  1. Adverse events, adverse drug reactions, patient reported tolerability

    Time frame: during 4 injection intervals

Secondary outcomes

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

    Time frame: after 4 injection intervals

  2. 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

  3. 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

  4. 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

  5. Treatment continuation rate

    Time frame: after 4 injection intervals

  6. Vital signs and anthropometric measurements (Blood pressure, heart rate, weight and waist circumference)

    Time frame: during 4 injection intervals

  7. Laboratory values (PSA, hemoglobin, hematocrit, HbA1C, T-chol, HDL-chol, LDL-chol, triglycerides)

    Time frame: during 4 injection intervals

  8. Digital rectal examination

    Time frame: during 4 injection intervals

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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)

Acronym: IPASS Nebido

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Dec 12, 2006
Registry last updated
Sep 24, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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