Efficacy and Safety of Testogel® in Men With Partial Androgen Deficiency of Aging Males (PADAM)
NCT ID: NCT00185198
Last Updated: 2014-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
363 participants
INTERVENTIONAL
2004-09-30
2007-10-31
Brief Summary
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Detailed Description
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Bayer Schering Pharma AG, Germany is the sponsor of the trial.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm 1
Testogel (Testosterone, BAYV001915)
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 2
Placebo
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
Interventions
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Testogel (Testosterone, BAYV001915)
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
Placebo
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
Eligibility Criteria
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Inclusion Criteria
* Willing to avoid significant change in the pattern of physical exercise and lifestyle for the duration of the study
Exclusion Criteria
50 Years
80 Years
MALE
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Vienna, Vienna, Austria
Graz, , Austria
Innsbruck, , Austria
Salzburg, , Austria
Vienna, , Austria
Helsinki, , Finland
Oulu, , Finland
Tampere, , Finland
Bonn, North Rhine-Westphalia, Germany
Dresden, Saxony, Germany
Leipzig, Saxony, Germany
Halle, Saxony-Anhalt, Germany
Magdeburg, , Germany
Dublin, , Ireland
Milan, , Italy
Napoli, , Italy
Roma, , Italy
Roma, , Italy
L'Hospitalet de Llobregat, Barcelona, Spain
Madrid, Madrid, Spain
Barcelona, , Spain
Gothenburg, , Sweden
Malmo, , Sweden
Stockholm, , Sweden
Reading, Berkshire, United Kingdom
Wigan, Manchester, United Kingdom
Cardiff, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Sheffield, , United Kingdom
Countries
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Other Identifiers
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2004-001545-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
307720
Identifier Type: OTHER
Identifier Source: secondary_id
91297
Identifier Type: -
Identifier Source: org_study_id
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