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.
Some of the risks related to bioidentical hormone replacement therapy are: 1  Risk of heart attack and other heart- related conditions. 2  Risk of stroke. 3  Risk of blood clotting that could ultimately lead to fatal pulmonary embolism. 4  Risk of increased triglycerides.