Use of Nebido® to Assess Tolerability and Treatment Outco... | NCT00410306

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

NCT00410306

Sponsor

Bayer

Status

Completed

Last Update Posted

Sep 24, 2010Estimated

Enrollment

1,493Actual

Phase

Not provided

Conditions

Male
Hypogonadism

Interventions

Testosterone Undecanoate (Nebido, BAY86-5037)

Countries

Australia
Austria
Bulgaria
Colombia
Czechia
Estonia
Germany
Hong Kong
Indonesia
Italy
Jordan
Kazakhstan
Latvia
Lebanon
Lithuania
Malaysia
Malta
Mexico
Moldova
North Macedonia
Philippines
Romania
Russia
Saudi Arabia
Singapore
Slovenia
South Korea
Spain
Taiwan
Thailand
Turkey (Türkiye)
Ukraine
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Sep 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2006

Primary Completion Date

Jul 2010Actual

Completion Date

Jul 2010Actual

First Submitted Date

Dec 11, 2006

First Submission Date that Met QC Criteria

Dec 11, 2006

First Posted Date

Dec 12, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 23, 2010

Last Update Posted Date

Sep 24, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,493Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1			Drug: Testosterone Undecanoate (Nebido, BAY86-5037)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Testosterone Undecanoate (Nebido, BAY86-5037)	Drug	Patients from routine practice	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse events, adverse drug reactions, patient reported tolerability		during 4 injection intervals

Secondary Outcomes

Measure	Description	Time Frame
Change in laboratory values (total testosterone, estradiol, SHGB, FSH, LH) from baseline to end of observation		after 4 injection intervals
Change in subjective assessment of the patient (overall sexual desire/libido, vigor/vitality, mood, ability to concentrate) from baseline to end of observation

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients from routine practice

Sampling Method

Non-Probability Sample

ID	Type	Description	Link
2005/00888
MP-04199
NE0601
39732

Facility	Status	City	State	ZIP	Country	Contacts
		Many Locations			Australia

ID	Term
D006058	Gonadal Disorders
D004700	Endocrine System Diseases