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.
There will be real and actual differences with my next pregnancy that will only exist because of the loss of my previous pregnancy. 1  I Will Worry 1 of 7. 2  Iâll Have to Take Progesterone Shots 2 of 7. 3  Weâll Use a Frozen Embryo 3 of 4  7. It Will be a Singleton Pregnancy 4 of 5  7. It Will Be Deemed High Risk Because of My âHistoryâ 5 of  7.