Postmenopausal females with Parkinson's Disease, stages I-IV are
needed for a study of the effect of ESTROGEN on parkinsonian symptoms
and levodopa response. This study requires two brief hospitalizations
as well as outpatient visits over a one month period while receiving
estrogen. Otherwise healthy, nonsmoking women with no personal or strong
family history of breast or uterine cancer are sought for this study.
Individuals desiring further information about this study or wishing to
be considered as participants are invited to call the Experimental
Therapeutics Branch at the NIH Clinical Center at 301-496-4604.
Alternatively, letters from patients or their referring physicians may be
addressed to Dr. Thomas N. Chase, NIH/NINDS, Building 10 / Room SC103, 10
Center Drive, MSC 1406, Bethesda, Maryland 20892-1406.
Editors note:
Some studies at NIH/ETB/NINDS have travel expenses available for those
not living in the Washington, DC area. To determine if this one has travel
expenses available, call Marge Gillespie, R.N. or Susan Kastris, R.N. at
1-800-362-3479.
STUDY TITLE: Estrogen Replacement Therapy in Parkinson's Disease
INTRODUCTION
We invite you (or your child) to take part in a research study at the
National Institutes of Health. It is important that you read and
understand several general principles that apply to all who take
part in our studies: (a) taking part in the study is entirely
voluntary; (b) personal benefit may not result from taking
part in the study, but knowledge may be gained that will benefit
others; (c) you may withdraw from the study at any time without
penalty or loss of any benefits to which you are otherwise entitled.
The nature of the study, the risks, inconveniences, discomforts, and
other pertinent information about the study are discussed below. If
you have personal, religious or ethical beliefs which you think might
limit the types of medical treatment (for example, blood transfusions)
that you would agree to receive (or would want your child to receive),
you should discuss them fully with your NIH physicians (or appropriate
members of the research team) before entering this study, You are urged
to discuss any questions you have about this study with the staff
members who explain it to you.
Purpose of the study
This study is designed to evaluate the clinical and biochemical
effects of estradiol, a potent and major estrogen hormone normally
secreted by the body, in the treatment of postmenopausal female
patients with Parkinson's Disease. This study will evaluate the
ability of this hormone to modify symptoms of Parkinson's Disease
and/or its treatment complications like dyskinesia.
Study plan
This study will take place over a six-week period during which time
you will be an inpatient at the NIH Clinical Center for up to five
days at four week intervals (maximum of 10 days). You will not be
able to participate in the study if you have not received a mandatory
complete gynecologic evaluation including a pelvic and breast
examination, Pap smear and a mammogram within nine months prior to
beginning the study. The results should be transmitted to us before
your inclusion in the study and should be satisfactory. Prior to
receiving the hormonal drug, you will also receive a medical history
and general physical examination, including a neurologic evaluation,
routine blood studies and EKG. A chest X-ray will be done if
you have not had one in the previous year. Brain CT or MRI will be
done if deemed necessary by the physician. The physical examination
given as part of this protocol is for the purposes of the protocol and
should not be construed as a complete assessment of your health. In
addition, motor function tests will be pertormed before and during the
drug study. You will also be asked to keep a diary of your parkinsonian
symptoms for 12 hours on two days prior to entry into the study and
during the study.
Following the above baseline work, you will begin receiving a hormonal
drug treatment made of estradiol. You will receive the drug (for 2 weeks)
and placebo (for 4 weeks) in a random order through a maximum of
four skin patches dally. for a total of 6 weeks. The number of patches
may be varied in order to reach a desired blood level. You will wear
these patches constantly and change them twice weekly. The placement of
the patches will be moved each time so as to prevent the development of
an allergic reaction to the adhesive. The hormonal dose administered is
approximately 4 times higher than what is normally recommended for
standard hormonal replacement therapy. You will also receive intravenous
doses of L-Dopa infused in your bloodstream over 10 minutes, for a
maximum of 3 doses on a single day and a maximum of $ days throughout
the whole protocol. Your standard Sinemet therapy will be withheld on
those days only and resumed as soon as the effects from the last infusion
of the day have vanished. Before each intravenous infusion, you will
receive an oral drug called carbidopa that you are used to taking as
part of your Sinemet tablets, to prevent nausea and vomiting.
Participation in this study requires that you temporarily discontinue
drugs like Eldepryl and your current hormonal replacement therapy for
at least 2 months prior to inclusion, and temporarily stop
antiparkinsonian medications like Permax or Parlodel for at least 2
weeks prior to inclusion. If these drug changes lead to discomfort,
you have the right to resume your original medication schedule and
withdraw from the study. You may temporarily feel worse because of the
new treatment.
During the study, motor function will be evaluated for a few hours
after each intravenous dose of L-Dopa, administered while you are
wearing your daily skin patches. Periodic videotaping may be done
under a separate written consent. Blood chemistry, hormone levels
and lipid levels will be obtained at baseline and then twice during
the study. Vital signs (blood pressure and pulse) will also be
monitored before and during each intravenous dose of L-Dopa. In
addition. 2 lumbar punctures (spinal taps) may be performed during
the study and cerebrospinal fluid collected for biochemical assays
(see below).
Risks
The beneficial and adverse effects of estradiol in postmenopausal
women at standard doses are well known. Although the dose you will
receive is substantially higher than the standard hormonal treatment
normally administered to postmenopausal women, all side effects should
be reduced by the short duration of estradiol exposure in this study
(2 weeks). The most important and publicized adverse effect of hormones
relates to a higher risk of developing cancer of the breast and uterus.
The risk is clearly dependent upon the duration of the exposure and
starts to rise only after 2 years of estradiol therapy. If your uterus
has not been surgically removed, there is also a possibility that you
may experience vaginal bleeding once the study is over due to the
sudden withdrawal of hormonal replacement. Certain preexisting
gynecologic conditions may predispose some women to this complication.
You will be referred back to your regular doctor or gynecologist for a
repeat examination should such a breakthrough bleeding be abundant or
prolonged.
One other risk relates to an elevation in triglyceride levels. Your
lipid profile will be monitored every two weeks during the protocol.
The known relationship between hormones and venous thrombosis
(susceptible to produce blood clots flowing to the lungs) is mainly
based on the experience of women on birth control pills. The skin
patches you will wear are different from birth control pills and the
duration of exposure to the patches is such that the risk of thrombosis
is minimized.
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