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.
<1%: The Mirena (levonorgestrel) has Progesterone in it which for many women makes them stop having a cycle temporarily. Once you have the Mirena (levonorgestrel) out, your periods should resume. About 2 in 100 women get pregnant with the Mirena (levonorgestrel) in place but it can happen.