Triptorelin for Ovary Protection in Childhood Onset Lupus
Systemic Lupus Erythematosus
About this trial
This is an interventional diagnostic trial for Systemic Lupus Erythematosus focused on measuring SLE, Lupus, Ovarian damage, Menopause
Eligibility Criteria
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.
Sites / Locations
- Children's Hospital of Los Angeles
- Children's Memorial Hospital
- Hackensack University Medical Center
- Morgan Stanley Children's Hospital of New York
- Cincinnati Children's Hospital Medical Center
- Columbus Children's Hospital
- Children's Hospital of Oklahoma
- Seattle Children's Hospital
- Children's Hospital of Wisconsin
- University of Sao Paulo
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Triptorelin T1
Triptorelin T2
Triptorelin T3
Triptorelin T4
Placebo
Triptorelin Pamoate 25 μg/kg body weight
Triptorelin Pamoate 50 μg/kg body weight
Triptorelin Pamoate 75 μg/kg body weight T3
Triptorelin Pamoate 100 μg/kg body weight T4
Normal Saline