Triptorelin for Ovary Protection in Childhood Onset Lupus

Inclusion Criteria:

• Females under the age of 21 and non-pregnant
• Tanner stage of 2 or above as determined by physical examination of breast stage
• Diagnosis with SLE using the updated American College of Rheumatology (ACR) Classification Criteria for SLE 1
• Severe SLE requiring cyclophosphamide therapy
• Bone mineral density z-score > - 2.0
• Must be using a medically acceptable form of birth control during the study and must not be pregnant at the screening visit
• No clinically significant abnormal findings other than those consistent with the diagnosis of childhood-onset SLE (cSLE) on the physical examination, medical history or clinical laboratory results during screening
• Currently on any combination of medication but must not have been treated with more than one dose of cyclophosphamide or other gonadotoxic medications in the past
• Voluntary consent or, if under the age of consent, assent to participate in this study with permission by a legal guardian

Exclusion Criteria:

• Male patients of any age
• Female patients with a Tanner stage of 1
• Positive blood pregnancy test at screening or taking oral or injectable birth-control medications
• Prior exposure to more than one dose of gonadotoxic medications including cyclophosphamide
• History of allergic or adverse response to triptorelin
• Diagnosed with hypogonadism prior to cyclophosphamide exposure
• Acutely life-threatening disease activity that prohibits inclusion in a clinical trial
• History of clinically significant gastrointestinal tract, renal, hepatic, endocrine, oncologic, pulmonary (asthma accepted), or cardiovascular disease; or a history of tuberculosis, epilepsy, diabetes, depression, psychosis, or any other non-cSLE condition, which in the opinion of the physician, would jeopardize the safety of the subject or impact the validity of the study results
• Patient age 18 years of younger with severe depression as defined by a CDI (Children's Depression Inventory) score of > 23 or a patient age 19 to 21 years with severe depression as defined by a BDI (Beck's Depression Inventory) score > 29
• Patient admits to suicidal thoughts at screening visit
• Bone mineral density lower than z = -2.0.