Use of Nebido® to Assess Tolerability and Treatment Outcomes in Daily Clinical Practice - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00410306

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	Phase
Male Hypogonadism	Drug: Testosterone Undecanoate	Phase IV

Drug Information available for: Testosterone Methyltestosterone Oxymesterone Testosterone enanthate Testosterone Propionate Testosterone undecanoate

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, 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)

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	1500
Study Start Date:	June 2006
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Group 1	Drug: Testosterone Undecanoate 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

Contacts

Contact: Bayer Clinical Trials Contact

clinical-trials-contact@bayerhealthcare.com

Show 34 Study Locations

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

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Responsible Party:	Bayer Schering Pharma AG ( Medical Affairs Therapeutic Area Head )
Study ID Numbers:	14203, 2005/00888, MP-04199, NE0601, IPASS Nebido
Study First Received:	December 11, 2006
Last Updated:	January 13, 2009
ClinicalTrials.gov Identifier:	NCT00410306
Health Authority:	Australia: Human Research Ethics Committee; Austria: Federal Ministry for Health and Women; 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; Indonesia: National Agency of Drug and Food Control; Italy: Ethics Committee; Korea: Food and Drug Administration; Macedonia: Ministry of Health; Malaysia: Ministry of Health; Philippines: Bureau of Food and Drugs; Romania: State Institute for Drug Control; Russia: Ministry of Health and Social Development of the Russian Federation; Singapore: Domain Specific Review Boards; Singapore: Health Sciences Authority; Taiwan: Institutional Review Board; Thailand: Ethical Committee; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Ukraine: Ministry of Health; United States: Food and Drug Administration

Keywords provided by Bayer:

Hypogonadism
Nebido
Testosterone
Observational Study

Study placed in the following topic categories:

Testosterone
Hypogonadism
Gonadal Disorders
Endocrine System Diseases

Methyltestosterone
Endocrinopathy
Testosterone 17 beta-cypionate

Additional relevant MeSH terms:

Anabolic Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Pharmacologic Actions
Androgens

ClinicalTrials.gov processed this record on January 16, 2009