NCT00185198

Brief Summary

The purpose of this study is to investigate the effect of a testosterone replacement therapy called Testogel in men with PADAM. The effects on body composition (lean, fat and bone) and other symptoms of PADAM and safety will be studied.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
363

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2004

Typical duration for phase_3

Geographic Reach
8 countries

30 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

April 2, 2014

Status Verified

April 1, 2014

Enrollment Period

2 years

First QC Date

September 9, 2005

Last Update Submit

April 1, 2014

Conditions

Androgens (Deficiency)Male

Keywords

Partial androgen deficiency of aging males (PADAM)

Outcome Measures

Primary Outcomes (1)

  • Lean body mass at 6 months

    baseline, month 6 and month 18

Secondary Outcomes (4)

  • Change in total body mass, fat mass and bone density

    baseline, month 6 and month 18

  • Evaluation of symptoms by the aging males symptoms rating scale

    baseline, month 6 and month 18

  • Change in testosterone

    baseline, month 6 and month 18

  • Safety parameters

    baseline, month 6 and month 18

Study Arms (2)

Arm 1

ACTIVE COMPARATOR
Drug: Testogel (Testosterone, BAYV001915)

Arm 2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Testogel (Testosterone, BAYV001915)DRUG

50mg (5g gel sachet), 75mg (5g+2.5g sachet) or 100mg (2x5g sachet) per day applied to the skin of the shoulders, arms or abdomen for 18 months

Arm 1
PlaceboDRUG

5g gel sachet, 5g+2.5g sachet or 2x5g sachets per day applied to the skin of the shoulders, arms or abdomen for 6 months followed by 12 months treatment with testosterone 1% gel as described for arm 1

Arm 2

Eligibility Criteria

Age50 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptomatic hypogonadism
  • Willing to avoid significant change in the pattern of physical exercise and lifestyle for the duration of the study

You may not qualify if:

  • Patients with any contraindication for testosterone use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (30)

Unknown Facility

Vienna, Vienna, 1090, Austria

Location

Unknown Facility

Graz, 8036, Austria

Location

Unknown Facility

Innsbruck, 6020, Austria

Location

Unknown Facility

Salzburg, 5020, Austria

Location

Unknown Facility

Vienna, 1021, Austria

Location

Unknown Facility

Helsinki, 00260, Finland

Location

Unknown Facility

Oulu, 90100, Finland

Location

Unknown Facility

Tampere, 33521, Finland

Location

Unknown Facility

Bonn, North Rhine-Westphalia, 53105, Germany

Location

Unknown Facility

Dresden, Saxony, 01067, Germany

Location

Unknown Facility

Leipzig, Saxony, 04103, Germany

Location

Unknown Facility

Halle, Saxony-Anhalt, 06112, Germany

Location

Unknown Facility

Magdeburg, 39310, Germany

Location

Unknown Facility

Dublin, Ireland

Location

Unknown Facility

Milan, 20123, Italy

Location

Unknown Facility

Napoli, 80131, Italy

Location

Unknown Facility

Roma, 00161, Italy

Location

Unknown Facility

Roma, 00186, Italy

Location

Unknown Facility

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Unknown Facility

Madrid, Madrid, 28007, Spain

Location

Unknown Facility

Barcelona, 08025, Spain

Location

Unknown Facility

Gothenburg, 41346, Sweden

Location

Unknown Facility

Malmo, 20502, Sweden

Location

Unknown Facility

Stockholm, 14186, Sweden

Location

Unknown Facility

Reading, Berkshire, RG2 7AG, United Kingdom

Location

Unknown Facility

Wigan, Manchester, WN1 1XX, United Kingdom

Location

Unknown Facility

Cardiff, CF14 5GJ, United Kingdom

Location

Unknown Facility

London, EC1A 7BE, United Kingdom

Location

Unknown Facility

London, NW3 2QG, United Kingdom

Location

Unknown Facility

Sheffield, S5 7AU, United Kingdom

Location

MeSH Terms

Interventions

Testosterone

Intervention Hierarchy (Ancestors)

AndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsTestosterone CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 16, 2005

Study Start

September 1, 2004

Primary Completion

September 1, 2006

Study Completion

October 1, 2007

Last Updated

April 2, 2014

Record last verified: 2014-04

Locations

GB(6)DE(5)IE(1)AU(5)FI(3)IT(4)SE(3)ES(3)