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.
What I know of Progesterone in pregnancy is that it is essentially unsafe due to the changes it can cause in the lining of the uterus (endometrium) and relaxation of the muscle of the uterus. These changes may increase the risk of miscarriage. Perhaps I am missing something here.