If the clinical trial is not of a drug or device subject to FDA regulation, and, thus, not an applicable clinical trial, at the time of the initiation of the trial, then the statement is not required.
Risks of Bioidentical Hormones. The jury's out on whether bio-identical hormones are safer. In 2002, a large federally funded study by the Women's Health Initiative revealed an increased risk of heart disease, breast cancer and stroke in women using synthetic prescription hormone replacement therapy.
No, a risk factor: Unopposed estrogen is a risk factor for uterine cancer but it does not always cause it. Unopposed estrogen means it is given without any Progesterone another female hormone. Somewhere between 4-8 out of every 1000 women receiving unopposed estrogen per year will get uterine cancer. Being obese probably makes the risk closer to 8/1000, whereas in thin women the risk is about 4/1000.