A Randomized Phase I Study of Testosterone Replacement in Patients With Low Risk Hormone Refractory Prostate Cancer
Sponsor study identifier
interventional
15
1 country
1
Study Start
June 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2008
Actual (reported)Study Completion
February 2009
Actual (reported)The purpose of this study is to see how safe Androderm® (the study drug) is at three different doses in subjects with early hormone refractory prostate cancer. In addition, information about hormonal levels and the effects of testosterone on quality of life including sexual functioning and muscle strength will be collected.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2009
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2004
Date type not reportedThis date has not been verified as actual or estimated.
February 2008
Actual (reported)February 2009
Actual (reported)August 20, 2010
Actual (reported)August 24, 2010
Actual (reported)Primary Study Objective is to determine the safety of Androderm® 2.5 mg, 5.0 mg, and 7.5 mg in patients with early hormone refractory prostate cancer.
To determine the safety of Androderm® 2.5 mg, 5.0 mg, and 7.5 mg in patients with early hormone refractory prostate cancer.
1-4 years
Secondary Study Objectives are to determine the effects of Androderm® 2.5 mg, 5.0 mg, and 7.5 mg on total and free testosterone levels and PSA as well as on QOL, sexual functioning, and muscle strength.
3-5 years
Study subjects will be randomized to one of the study arms: 2.5 mg of Androderm®.
Study subjects will be randomized to one of the study arms: 5.0 mg of Androderm®.
Study subjects will be randomized to one of the study arms: 7.5 mg of Androderm®.
Subjects will be asked to replace the study drug patch every 24 hours at night following the written and verbal instructions you will receive. The study drug patch should be placed over a small amount of a steroid cream on the skin to reduce irritation.
Subjects will be asked to replace the study drug patch every 24 hours at night following the written and verbal instructions you will receive. The study drug patch should be placed over a small amount of a steroid cream on the skin to reduce irritation.
University of Chicago
Chicago, Illinois, 60637, United States
Walter M Stadler, MD
University of Chicago
15 participants (actual enrollment reported by the registry).
First Submitted
August 20, 2010
First Posted
August 24, 2010
Study Start
June 2004
Date type not reportedThis date has not been verified as actual or estimated.
Prostatic Acid Phosphatase (PAP) Vaccine in Patients With Prostate Cancer
Subjects will be asked to replace the study drug patch every 24 hours at night following the written and verbal instructions you will receive. The study drug patch should be placed over a small amount of a steroid cream on the skin to reduce irritation.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
February 2008
Actual (reported)Study Completion
February 2009
Actual (reported)Last Updated
November 29, 2023
Record last verified: 2023-11
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Source: ClinicalTrials.gov.
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