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.
Talk to your doctor about the risks of taking this medication. Medications like progesterone may cause abnormal blood clotting. This may cut off the blood supply to the brain, heart, lungs, or eyes and cause serious problems. Call your doctor if you experience any of the symptoms listed above as serious side effects.