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.
If you still have your uterus, taking estrogen without progesterone raises your risk for cancer of the endometrium, the lining of the uterus. Since the cells from the endometrium arenât leaving your body during your period any more, they may build up in your uterus and lead to cancer.