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.
Obese women are also at increased risk because the more you weigh, the more testosterone your body produces. The worst offenders: Because progesterone has some androgenic qualities similar to testosterone, any progestin-only pills or the Mirena IUD can cause acne.