Number: CTSU ACOSOG A221102 Principal Investigator: Aft, Rebecca
Title: Randomized Double-Blind Placebo Controlled Study of Subcutaneous Testosterone in the Adjuvant Treatment of Postmenopausal Women with Aromatase Inhibitor Induced Arthralgias
Phase: III Disease Site: Breast, Female
Participating Site(s):
Main Campus
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It is well known that treatment with an aromatase inhibitor (AI) can cause side effects that result in symptoms such as joint pain and stiffness, which can interfere with activities of daily living. In some patients, the treatment has to be stopped because of these symptoms. The purpose of this study is to compare the effects, good and/or bad, of the study agent, testosterone, with a placebo (an inactive agent) on joint pain caused by taking aromatase inhibitors. The testosterone
will be mixed with a little anastrozole to prevent any medication from turning into estrogen (testosterone by itself may turn into estrogen – mixing the testosterone with a small amount of anastrozole prevents
this from occurring). The testosterone/placebo is a pellet that is placed just under your skin on the upper buttocks or gluteal region. In this study, you will receive either the testosterone or placebo. You will not
receive both.
More Information: Website
Internal Protocol Documents (requires Siteman administrative database password)