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.
AP104: The High Risk Endometrial Biopsy Page 13 poor surgical risks, are candidates for hormonal (progestin) therapy. Systemic progestins can successfully ablate up to 90% of endometrial precancers in young women 14, although it is not possible in advance to predict that fraction which will respond.