Efficacy and Tolerability of Testogel/Nebido in Combinati... | NCT00847314

Studies
Efficacy and Tolerability of Testogel/Nebido in Combination With Exercise and Diet in Hypogonadal Male Patients

NCT00847314

Sponsor

Bayer

Status

Completed

Last Update Posted

Jun 21, 2013Estimated

Enrollment

30Actual

Phase

Not provided

Conditions

Hypogonadism

Interventions

Testosterone Undeconate (Nebido-R, BAY86-5037)

Countries

Germany

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

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NE0602	Other Identifier	Other company ID

Status Module

Record Verification Date

Jun 2013

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

Jun 2007

Primary Completion Date

Oct 2008Actual

Completion Date

Oct 2008Actual

First Submitted Date

Feb 17, 2009

First Submission Date that Met QC Criteria

Feb 18, 2009

First Posted Date

Feb 19, 2009Estimated

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

Jun 19, 2013

Last Update Posted Date

Jun 21, 2013Estimated

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

With advancing age testosterone levels decline in men. Low testosterone levels plus certain symptoms are called "Late Onset Hypogonadism (LOH)". Adipose tissue may contribute to testosterone deficiency. On the other hand testosterone deficiency again leads to a decrease in lean body mass and an increase in fat mass - one of the clinical signs / symptoms of LOH. Lifestyle changes (diet, exercise) alone or in combination with testosterone replacement (TRT), have an influence on the symptoms of LOH. The aim of this study is to assess the additional impact of TRT on Aging Male Symptom Score (AMS) and adiposity (waist circumference) in patients, who are on a diet and exercise program.

Detailed Description

Not provided

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

30Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Testosterone Undeconate (Nebido-R, BAY86-5037)	Drug	Male patients > 35yrs in medical practices fulfilling all criteria for documentation.	Group 1

Measure	Description	Time Frame
Waist Circumference		At each visit

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male patients > 35yrs
Waist Circumference > 102cm
Clinically and biochemically confirmed hypogonadism (testosterone group)
Willingness to attempt weight optimization

Exclusion Criteria:

Androgen dependent carcinoma of the prostate or male mammary gland, past or present history of liver tumours
hypersensitivity towards the active pharmaceutical ingredient or other ingredients.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Male patients in medical practices > 35yrs fulfilling all criteria for documentation.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D007006	Hypogonadism
D056128	Obesity, Abdominal
D009043	Motor Activity

Ancestor Terms

ID	Term
D006058	Gonadal Disorders
D004700	Endocrine System Diseases
D009765	Obesity
D050177	Overweight

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D043343	Testosterone Propionate

Ancestor Terms

ID	Term
D013739	Testosterone
D000737	Androstenols
D000736	Androstenes
D000731	Androstanes

Browse Leaves

Not provided

Browse Branches

Not provided