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

Hypogonadism Clinical Trial

— IPASS Nebido  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00410306
• Other study ID #: 14203
• Secondary ID: 2005/00888MP-041
• Status: Completed
• Phase: N/A
• First received: December 11, 2006
• Last updated: September 23, 2010
• Start date: October 2006
• Est. completion date: July 2010

Study information

• Verified date: September 2010
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and WomenAustralia: Human Research Ethics CommitteeBulgaria: Bulgarian Drug AgencyColombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y AlimentosCzech Republic: State Institute for Drug ControlGermany: Federal Institute for Drugs and Medical DevicesUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyIndonesia: National Agency of Drug and Food ControlItaly: Ethics CommitteeKorea: Food and Drug AdministrationKazakhstan: National Center for Expertise of Medicinal DrugsMacedonia: Ministry of HealthMalaysia: Ministry of HealthPhilippines: Bureau of Food and DrugsRomania: State Institute for Drug ControlRussia: Ministry of Health of the Russian FederationSingapore: Domain Specific Review BoardsSingapore: Health Sciences AuthorityThailand: Ethical CommitteeTaiwan: Institutional Review BoardUkraine: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1493
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypogonadism
• Male

Intervention

Drug:
• Testosterone Undecanoate (Nebido, BAY86-5037)
Patients from routine practice

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Australia,  Austria,  Bulgaria,  Colombia,  Czech Republic,  Estonia,  Germany,  Hong Kong,  Indonesia,  Italy,  Jordan,  Kazakhstan,  Korea, Republic of,  Latvia,  Lebanon,  Lithuania,  Macedonia, The Former Yugoslav Republic of,  Malaysia,  Malta,  Mexico,  Moldova, Republic of,  Philippines,  Romania,  Russian Federation,  Saudi Arabia,  Singapore,  Slovenia,  Spain,  Taiwan,  Thailand,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events, adverse drug reactions, patient reported tolerability		during 4 injection intervals	Yes
Secondary	Change in laboratory values (total testosterone, estradiol, SHGB, FSH, LH) from baseline to end of observation		after 4 injection intervals	No
Secondary	Change in subjective assessment of the patient (overall sexual desire/libido, vigor/vitality, mood, ability to concentrate) from baseline to end of observation		after 4 injection intervals	No
Secondary	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		after 4 injection intervals	No
Secondary	Patient reported outcome at end of observation (satisfaction with current androgen therapy, comparison to previous androgen therapy, if applicable)		after 4 injection intervals	No
Secondary	Treatment continuation rate		after 4 injection intervals	No
Secondary	Vital signs and anthropometric measurements (Blood pressure, heart rate, weight and waist circumference)		during 4 injection intervals	Yes
Secondary	Laboratory values (PSA, hemoglobin, hematocrit, HbA1C, T-chol, HDL-chol, LDL-chol, triglycerides)		during 4 injection intervals	Yes
Secondary	Digital rectal examination		during 4 injection intervals	Yes

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