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

Sponsor:	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
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:

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

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 and Social Development 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 February 09, 2012