Ovary Protection Medication Study for Childhood Onset Lupus
What is the purpose of this study?
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.
Who can participate?
Female patients between 9 and 21 who newly require chemotherapy for Severe lupus may qualify for this study.
- Adult Studies
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 receive 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.
Do participants receive pay, compensation or reimbursement?
Compensation will be provided.
Who should I contact for more information?
Shannen Nelson, RN, BSN
Cincinnati Children's Hospital Medical Center
Department of Rheumatology
3333 Burnet Ave., Cincinnati, OH 45229-3039