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.
Progesterone (brand names include Provera, Endometrin, Crinone, Prometrium or Cyclogest) is one of the primary female reproductive hormones, which is produced immediately after ovulation and helps build up and ready the uterine lining for implantation of a fertilized egg.