Trial Information

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 lupus.

Inclusion criteria:

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 study:

Blood draws.
Ovarian ultrasounds.
DEXA scanning (a test to determine bone strength and amount of bone).
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 stage).
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 future.

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 attention: none.
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 cyclophosphamide therapy.

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
Phone: 513-636-5484
Email: shannen.nelson@cchmc.org

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Research Center Information: Cincinnati Children's Hospital Medical Center/Cincinnati Children's Research Foundation

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