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 Blood Hormone Levels And Breast Cancer Risk Female sex hormones such as progesterone and estrogen are known to participate in the biochemical and genetic cascades that lead to breast cancer. 2  Artificial female sex hormâ¦.