Safety Procedures
Your safety is a priority to us. Below, we outline some of the risks
that are associated with your participation in the study and the steps
that we take to minimize these risks.
Estradiol and medroxyprogesterone acetate
You have a 33% chance of being randomized to receive oral estradiol
(1 mg/day) followed by medroxyprogesterone acetate (10 mg/day) for 10 days.
Hormone therapy may cause nausea, weight gain, breast tenderness and/or
enlargement, headache and depression in some women. Also, a common but
not serious risk of hormone therapy is breakthrough or irregular uterine
bleeding. After discontinuing hormone therapy at the end of the trial,
you may experience an increase in menopausal symptoms, including hot flashes,
mood swings and insomnia. For any women taking hormone therapy, there is
a slight increase in the risk of coronary heart disease, stroke, deep vein
thrombosis (a blood clot in the vein), or pulmonary embolism (a blocking
of an artery in the lungs). The risk is small and occurs in only 18 of
10,000 women taking hormone therapy. There is also an increased risk of
gallbladder disease and cancers of the breast, liver and kidney. You
should tell your doctor if you or any close family members have had
problems of this type. There is a rare but serious risk of endometrial
hyperplasia (thickening of the uterine lining) in women taking unopposed
estrogen. In order to prevent this risk, medroxyprogesterone acetate
should be paired with estrogen. A recent study (WHI / WHIMS) also showed
that the risk of dementia for women 65 years of age and older taking
hormone replacement therapy was twice as high compared to those receiving
placebo, although the risk is small and occurs in only 23 of 10,000 women
taking HRT. The overall risk of dementia in women in their 40s and 50s is
very small.
Soy
You have a 33% chance of being randomized to receive soy in the
form of a Novasoy® 400 pill. Theoretically, Novasoy® 400 may act
like the hormone estrogen on the breast or uterus, but clinical
trials have not reported these adverse events with Novasoy® 400 use
or with other soy products. Novasoy® 400 is a plant-derived compound
that is commercially available in the United States. There are no known
side effects of Novasoy® 400.
Placebo
You have a 33% chance of being randomized to receive placebo.
The placebo pill is filled with lactose. There is a slight risk
of an increase in the risks of lactose intolerance symptoms associated
with taking the placebo pills. If you are on placebo, you may experience
an increase in menopausal symptoms, including hot flashes, mood swings and
insomnia.
Tests of Mental Abilities
You may find some of the tests of memory and other mental abilities
to be challenging, frustrating, boring or stressful. We selected the
tests so that very few people obtain a perfect score. By choosing
challenging tests we can better observe improvements over time and
with treatment.
Psychological Interview
The questions in the psychological review ask for sensitive information
about your mental health. You may be uncomfortable answering some of the
questions about your psychological health. There is a chance that the
psychological review will indicate that you currently have or have had
a psychological disorder. If that occurs, you will not qualify for this
study and you will be given the opportunity to be referred to a clinician
for a follow-up. Completion of this psychological review is necessary to
participate in this research study. It is necessary for us to include women
without a psychological disorder so that we can examine the impact of our
study medications on typical psychological symptoms of the menopause,
including depressive symptoms and anxiety symptoms.
Questionnaires
Some people are uncomfortable, anxious, or distressed when
completing questionnaires about child hood experiences, mood or hot
flushes. While completing the survey instruments, you can tell the
researcher that you feel uncomfortable or do not care to answer a
particular question.
Blood Draws
Blood draws may result in discomfort, bruising, light-headedness,
pain and/or inflammation at the needle stick site. A trained phlebotomist
will be conducting the blood draw.
Heart Rate and Hot Flash Monitor
The heart rate monitor does not involve significant risk. Wearing
the monitor can be a minor inconvenience. The monitor poses no risk
of electric shock. Potential side effects of the monitor include (1)
allergy to the paper or adhesive on the disposable electrodes
(minor, 1%), (2) itching at the site of electrode attachment (minor, 4%)
and (3) discoloration of the skin from the electrode gel. Following each
monitoring session, the research assistant will question you about any
discomfort you may experience due to wearing either device.
Loss of confidentiality
There is a risk of loss of confidentiality in this study. The only people
who will know that you are a research subject are members of the research
team, and, if appropriate, your physicians and nurses. No information about
you, or provided by you during the research will be disclosed to others
without your written permission, except if necessary to protect your rights
or welfare (for example, if you are injured and need emergency care or when
the UIC Institutional Review Board monitors the research or consent process)
or if required by law.
When the results of the research are published or discussed in conferences,
no information will be included that would reveal your identity. Any
information that is obtained in connection with this study and that can
identify you will remain confidential and will be disclosed only with your
permission or as required by law.
Authorized representatives of the National Institutes of Health/ National
Institutes of Mental Health (NIH/NIMH) may need to review records of individual
subjects. As a result, they may see your name; but they are bound by
rules of confidentiality not to reveal your identity to others.
Raw data sheets will be kept under lock and key at the Neuropsychiatric
Institute. Data will be entered and maintained in a secure non-network
computer database that requires a login ID number and password that will
be made available only to immediate study personnel and Investigators.