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Therapeutic Areas: Immunology | Musculoskeletal | Rheumatology | Family Medicine
Disease Category: Lupus
Location: United States, OH
Ovary Protection Medication Study for Childhood Onset Lupus (ages 21 and under).
The purpose of this study is to determine the safety and
effectiveness of an ovary protection medication (triptorelin), and
its dosage and the time necessary to suppress ovaries to protect
them against harmful effects of chemotherapy used in treating
- Female patients between 9 and 21 who newly require chemotherapy
for severe lupus may qualify for this study.
What is involved?
This study lasts for 23 months and includes 24 visits. The
following is a list of procedures that will take place during the
- Blood draws.
- Ovarian ultrasounds.
- DEXA scanning (a test to determine bone strength and amount of
- IV placement for blood draws during GAST test (to test for
function of ovaries).
- Questionnaires (written).
- Tanner staging (a physical exam that will include an
examination of subject’s breasts to determine physical development
- Medical exam by physician.
What are the benefits?
Subjects may or may not benefit from this study. Patients treated
with triptorelin may avoid the development of premature ovarian
failure (POF) or a decrease in their remaining ovarian reserve. The
average risk of POF with cyclophosphamide (a medication used to
treat severe lupus) is estimated to be at 11% (range 0 - 37%). The
information gained from the study may help patients in the
Will I get all the facts about the study?
Parents who are interested in having their child participate, and
adult subjects, will be given a consent form that thoroughly
explains all of the details of the study. It includes all of the
procedures, the risks, the benefits, the compensation, who to
contact with questions or concerns, and more. A member of the study
staff will review the consent form with you and will be sure that
all of your questions are answered. Study procedures will not begin
until the parent/guardian (or you, the participating study subject)
have signed this form and, if of age, the child has given at
minimum his/her verbal agreement.
What are the risks?
Required study blood draws may cause minor discomfort, bruises and
infections. The study personnel will attempt to combine study blood
draws with those necessary for all patients with lupus.
Along with the needed effects of the study medication there may be
some unwanted effects:
- Side effects of triptorelin that need frequent medical
- Side effects of triptorelin that occur infrequently and may
need medical attention: bladder pain; bloody or cloudy urine; high
blood pressure; lower back or side pain; painful urination; pale
skin; unusual tiredness or weakness.
- Side effects that commonly occur but don’t need medical
attention: decreased interest in sexual intercourse; feeling of
warmth or redness of the face neck, arms and occasionally upper
chest; headache; or sudden sweating.
- Side effects that occur infrequently and don’t need medical
attention: crying; diarrhea; dizziness; injection site pain;
itching; leg pain; mental depression; rapidly changing moods;
trouble sleeping or getting to sleep; or vomiting.
There is a small amount of radiation necessary when doing a DEXA
scan. This amount is less than the amount of radiation required for
a single chest x-ray.
Whenever possible, the study personnel will schedule study tests
around the time when you or your child are already coming to clinic
or have to be admitted to the hospital because of required
There may be unknown or unforeseen risks associated with study
participation. Since this is a new experimental treatment, many
side effects could occur. These side effects could potentially be
serious or even fatal. The drug, triptorelin, will be discontinued
if serious side effects develop. Because the dose of triptorelin
will be increased as more patients are treated, it is more likely
that some patients will have severe side effects than if one
standard dose was used.
For more information,
Shannen Nelson, RN, BSN
Cincinnati Children's Hospital Medical Center/Cincinnati Children's Research Foundation
Department of Rheumatology
3333 Burnet Ave.
Cincinnati, OH 45229
If you would like to learn more about participating in this study, please send an email message using the form below.
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