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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00410306
First received: December 11, 2006
Last updated: September 23, 2010
Last verified: September 2010
History of Changes
  Purpose

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 Intervention
Male
Hypogonadism
 Drug: Testosterone Undecanoate (Nebido, BAY86-5037)

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Adverse events, adverse drug reactions, patient reported tolerability [ Time Frame: during 4 injection intervals ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in laboratory values (total testosterone, estradiol, SHGB, FSH, LH) from baseline to end of observation [ Time Frame: after 4 injection intervals ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Treatment continuation rate [ Time Frame: after 4 injection intervals ] [ Designated as safety issue: No ]
  • Vital signs and anthropometric measurements (Blood pressure, heart rate, weight and waist circumference) [ Time Frame: during 4 injection intervals ] [ Designated as safety issue: Yes ]
  • Laboratory values (PSA, hemoglobin, hematocrit, HbA1C, T-chol, HDL-chol, LDL-chol, triglycerides) [ Time Frame: during 4 injection intervals ] [ Designated as safety issue: Yes ]
  • Digital rectal examination [ Time Frame: during 4 injection intervals ] [ Designated as safety issue: Yes ]

Enrollment: 1493
Study Start Date: October 2006
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Testosterone Undecanoate (Nebido, BAY86-5037)
Patients from routine 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients from routine practice

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00410306

  Show 33 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Medical Affairs Therapeutic Area Head, Bayer Schering Pharma AG
ClinicalTrials.gov Identifier: NCT00410306     History of Changes
Other Study ID Numbers: 14203, 2005/00888, MP-04199, NE0601, 39732
Study First Received: December 11, 2006
Last Updated: September 23, 2010
Health Authority: Austria: Federal Ministry for Health and Women
Australia: Human Research Ethics Committee
Bulgaria: Bulgarian Drug Agency
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Czech Republic: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Indonesia: National Agency of Drug and Food Control
Italy: Ethics Committee
Korea: Food and Drug Administration
Kazakhstan: National Center for Expertise of Medicinal Drugs
Macedonia: Ministry of Health
Malaysia: Ministry of Health
Philippines: Bureau of Food and Drugs
Romania: State Institute for Drug Control
Russia: Ministry of Health of the Russian Federation
Singapore: Domain Specific Review Boards
Singapore: Health Sciences Authority
Thailand: Ethical Committee
Taiwan: Institutional Review Board
Ukraine: Ministry of Health

Keywords provided by Bayer:
Hypogonadism
Nebido
Testosterone
Observational Study

Additional relevant MeSH terms:
Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on May 19, 2013