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.
Do not confuse Provera (medroxyprogesterone) with Proscar (finasteride) or Prozac (fluoxetine). Only the 150 mg/mL vial should be used for contraception. Injectable medroxyprogesterone may lead to bone loss, especially in women younger than 21 yr. Injectable medroxyprogesterone should be used for >2 yr only if other methods of contraception are inadequate. If used long term, women should use supplemental calcium and vitamin D, and monitor bone mineral density.