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.
It can also be made in a laboratory. âProgestinâ is a general term for a substance that causes some or all of the biologic effects of progesterone. The term progestin is sometimes used to refer to the progesterone made in the laboratory that is in oral contraceptives and hormone replacement therapy.t can also be made in a laboratory. âProgestinâ is a general term for a substance that causes some or all of the biologic effects of progesterone. The term progestin is sometimes used to refer to the progesterone made in the laboratory that is in oral contraceptives and hormone replacement therapy.