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.
You need to find a holistic doctor in your area that does bio identical hormone replacement therapy. He will monitor all of your hormones (even those your gyn doesn't think is necessary to check) through blood work and can get you where you can function again. Many of the menopause symptoms mimic stress, insomnia, you name it. I was on zoloft for 16 years (!!!!!!) and had to be weaned off to start this therapy. My doctor feels I really didn't need zoloft, but was lacking in progesterone. Normal doctors know NOTHING about this bio stuff.