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.
Possible side effects of synthetic progesterone include breast tenderness or discharge, hives, itching, skin rash, acne, hair growth or hair loss, spotting or break-through bleeding, changes in menstrual periods, vaginal itching or discharge, changes in appetite, increased or decreased weight, nausea, stomach pain, bloating, fever, sleep problems (insomnia), and jaundice (yellowing of the skin or eyes), or skin color changes.