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What
are the risks?
The answer to this
question depends on the type of study. Some studies involve little or
no risk, while others may be very risky. Most studies are somewhere in
between. The researchers doing the study will explain all of the risks
to you. You should get answers to all of your questions about your risk
before you agree to be in the study.
There are two risks
that are particularly important for women:
Pregnancy - When a
woman is pregnant, any drugs that she takes may have an effect on her
fetus. Because the risks of new drugs and other treatments to the fetus
are not always known, women who may become pregnant must take these risks
into consideration. During the informed consent process, you may be asked
if you are pregnant or are considering getting pregnant. If you are sexually
active, the researcher will ask you to use a reliable form of birth control
while you are in the study. You may also be asked to have regular pregnancy
tests as part of the study.
Birth Control Pills
and Hormone Replacement Therapy - Birth control pills, other hormonal
contraceptives (such as Norplant or Depo-Provera), and hormone replacement
therapy during and after menopause can affect how your body handles drugs.
It is important to tell the doctor performing a medical research study
about what hormones and other drugs you are taking, even "natural"
hormones, herbs and dietary supplements.

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