Low Testosterone
Qualifying
You are being asked to voluntarily participate in a research study of a drug called AndroGel 1.62%. AndroGel 1.62% is a testosterone replacement therapy (TRT) approved by the U.S. Food and Drug Administration (FDA) to treat certain conditions associated with a deficiency or absence of natural testosterone (a male hormone) production.
You are being asked to join this study because you may have hypogonadism (a condition where low blood testosterone levels are associated with clinical symptoms). While you may not have the specific causes of low testosterone that AndroGel 1.62% is currently approved for, this study is designed to answer further questions about the effect of TRT, which could not be answered in earlier studies prior to the drug’s approval. The major question this study is trying to answer is how safe and effective is TRT in people with low testosterone (hypogonadism) and either cardiovascular (CV) disease or risk factors for CV disease.
Schedule
If you qualify for the study, your participation may last up to approximately 5 years depending on when you begin the study and when the study ends. There are up to 27 required study-related contacts (approximately 17 office visits and 10 phone calls).
Cost
Neither you nor your insurance company will have to pay for the study drug (AndroGel 1.62% or placebo) or procedures that are done only for the study.
Compensation for Participation
You may be paid $85.00 for each completed office visit with the exception of Screening Visit 3, if necessary: $50.00.
