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.
In general, estradiol causes cells to proliferate and progesterone causes cells to differentiate and grow up. Estradiol causes the femaleness in women. It causes the breasts to grow and the hips to round out. However, too much estradiol can cause an increased incidence of breast cancer. Women who have menarche early and have menopause later are at a greater risk of breast cancer.