search
Back to results

Assessment of Long Term Treatment With Testosterone Undecanoate in Males With Hypogonadism

Primary Purpose

Hypogonadism

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Testosterone undecanoate (TU) - NebidoTM
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypogonadism

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Hypogonadal men, aged 18-75 years with low serum total testosterone (TT) levels and symptoms of androgen deficiency Exclusion Criteria: Tumors of the prostate or the male mammary gland including suspicion thereof. Past or present liver tumors or chronic hepatic disease with impairment of liver function, Severe acne.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

Outcomes

Primary Outcome Measures

Efficacy and Safety of long term treatment with TU under real-life conditions

Secondary Outcome Measures

Assessment of treatment satisfaction by patient

Full Information

First Posted
September 16, 2005
Last Updated
December 29, 2014
Sponsor
Bayer
search

1. Study Identification

Unique Protocol Identification Number
NCT00220298
Brief Title
Assessment of Long Term Treatment With Testosterone Undecanoate in Males With Hypogonadism
Official Title
Open One-arm Study to Investigate Safety and Efficacy of Intramuscular Injections of 1000 mg Testosterone Undecanoate (TU) in Hypogonadal Men at Variable Intervals During a 136-week to 192-week Treatment Including Pharmacokinetics
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate the preparation of testosterone undecanoate under conditions which resemble real-life situations.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Testosterone undecanoate (TU) - NebidoTM
Intervention Description
Drug treatment with 14 injections of one ampoule of Nebido (1000 mg of testosterone undecanoate) at individually adjusted injection intervals
Primary Outcome Measure Information:
Title
Efficacy and Safety of long term treatment with TU under real-life conditions
Time Frame
Every 3 months during treatment and after final injection
Secondary Outcome Measure Information:
Title
Assessment of treatment satisfaction by patient
Time Frame
6,10, and 14 injections

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hypogonadal men, aged 18-75 years with low serum total testosterone (TT) levels and symptoms of androgen deficiency Exclusion Criteria: Tumors of the prostate or the male mammary gland including suspicion thereof. Past or present liver tumors or chronic hepatic disease with impairment of liver function, Severe acne.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Nürnberg
State/Province
Bayern
ZIP/Postal Code
90441
Country
Germany
City
Marburg
State/Province
Hessen
ZIP/Postal Code
35037
Country
Germany
City
Wolfsburg
State/Province
Niedersachsen
ZIP/Postal Code
38440
Country
Germany
City
Münster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48129
Country
Germany
City
Halle
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06112
Country
Germany
City
Naumburg
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06618
Country
Germany
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04299
Country
Germany
City
Jena
State/Province
Thueringen
ZIP/Postal Code
07740
Country
Germany
City
Jena
State/Province
Thueringen
ZIP/Postal Code
07743
Country
Germany
City
Eisenberg
State/Province
Thüringen
ZIP/Postal Code
07607
Country
Germany
City
Gera
State/Province
Thüringen
ZIP/Postal Code
07551
Country
Germany
City
Berlin
ZIP/Postal Code
10249
Country
Germany
City
Berlin
ZIP/Postal Code
12159
Country
Germany
City
Leipzig
ZIP/Postal Code
04289
Country
Germany

12. IPD Sharing Statement

Citations:
Citation
Behre HM and Elliesen J. Safety and efficacy of intramuscular injections of 1000 mg testosterone undecanoate: A prospective multicenter study in hypogonadal men under conditions resembling real-life situations. Proceedings of the 22nd Annual European Association of Urology (EAU); 2007 Mar 22; Berlin, Germany. Eur Urol Suppl 2007;6(2):108.
Results Reference
result

Learn more about this trial

Assessment of Long Term Treatment With Testosterone Undecanoate in Males With Hypogonadism

We'll reach out to this number within 24 hrs