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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00410306
Recruitment Status : Completed
First Posted : December 12, 2006
Last Update Posted : September 24, 2010
Information provided by:

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.

Condition or disease Intervention/treatment
Male Hypogonadism Drug: Testosterone Undecanoate (Nebido, BAY86-5037)

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.

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Study Type : Observational
Actual Enrollment : 1493 participants
Observational Model: Cohort
Time Perspective: Prospective
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 Start Date : October 2006
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Group/Cohort Intervention/treatment
Group 1 Drug: Testosterone Undecanoate (Nebido, BAY86-5037)
Patients from routine practice

Primary Outcome Measures :
  1. Adverse events, adverse drug reactions, patient reported tolerability [ Time Frame: during 4 injection intervals ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients from routine practice

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00410306

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Sponsors and Collaborators
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Study Director: Bayer Study Director Bayer

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Responsible Party: Medical Affairs Therapeutic Area Head, Bayer Schering Pharma AG Identifier: NCT00410306     History of Changes
Other Study ID Numbers: 14203
First Posted: December 12, 2006    Key Record Dates
Last Update Posted: September 24, 2010
Last Verified: September 2010
Keywords provided by Bayer:
Observational Study
Additional relevant MeSH terms:
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Gonadal Disorders
Endocrine System Diseases
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents