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.
1 Women who have had breast cancer or have a family history of breast or ovarian cancer have an increased risk of ovarian cancer.  Women who take estrogen replacement only (not with progesterone) for 5 years or more may have a high risk of ovarian cancer. Birth control pills, however, decrease the risk of ovarian cancer.