Triptorelin for Ovary Protection in Childhood Onset Lupus

Lupus is an autoimmune disease that may harm all organs in the body and especially affects the kidney, brain, skin and lungs. Cyclophosphamide is a very effective medication to treat lupus, but it can damage the ovaries (pair of reproductive organs).

Only female lupus patients may participate in this study.

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.