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.
Sometimes low progesterone symptoms can be more dangerous. Chronic depression or anxiety, for instance, could lead to risk to suicidal behavior. Low progesterone levels can create dysfunction of the thyroid gland, and most seriously, certain forms of cancer may be more likely, including uterine cancer.