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 therapy boosts low progesterone levels by supplementing progesterone either synthetically or naturally. Most women opt for natural bioidentical progesterone as safer alternative to synthetic progesterone to minimize the risk of breast cancer and heart disease. Progesterone therapy is either administered by cream, gel, patch or pellet insertion, usually depending on availability, cost and convenience of use.