Triptorelin for Ovary Protection in Childhood Onset Lupus

Completed · Phase 2 · Has a placebo group

Conditions studied: Systemic Lupus Erythematosus

In brief

The purpose of this study is to test the safety of triptorelin when used for the protection of the ovaries (pair of female reproductive organs) during cyclophosphamide therapy for systemic lupus erythematosus (SLE; lupus) and to see what effects (good or bad) it has on patients. The study will be done with female patients who have been diagnosed with systemic lupus erythematosus, are younger than 21 years of age, and require intravenous cyclophosphamide to control the disease. Each patient will be in the study for approximately 23 months, until 4 months after the intravenous cyclophosphamide treatment has been completed. This study is currently being conducted at 3 sites across the United States and Brazil (Los Angeles, Cincinnati and San Paulo Brazil). A total of 50 patients will participate in this study. Each patient will be randomized (assigned) to one of 5 groups. Randomization means that patients are put into a group completely by chance. It is like flipping a coin. Neither the patient nor the study staff knows what group the patient is in. The patient has a 20% chance of being placed in any group. This is a dose escalation study, each patient will receive the first dose of the study drug (T1 - T4, placebo). If a patient has complete ovarian suppression on day 27 after the initial injection of study drug, then she will remain on this weight-adjusted dose of study drug throughout the study. The dose will be increased up for a weight gain of 5kg or greater. The dose will not be adjusted downward for a weight loss. If COS was not maintained with the 1st dose of study drug, then the subsequently injected 2nd dose will be increased by 25% or at least 20 microgram/kg/dose. The maximal dose of 150 microgram/kg/dose will not be exceeded. The absolute maximum dose is 20 mg. Funding Source: FDA OOPD and Watson Pharmaceuticals

Key facts

Study ID: NCT00124514
Run by: Children's Hospital Medical Center, Cincinnati
People needed: 31
Starts: 2003-06-01
Expected to finish: 2014-03-01
Last updated by the study team: 2021-01-05

Who can join

Age: 9 and older, up to 21. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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.

Where it is running

Children's Hospital of Los Angeles — Los Angeles, California, United States
Children's Memorial Hospital — Chicago, Illinois, United States
Hackensack University Medical Center — Hackensack, New Jersey, United States
Morgan Stanley Children's Hospital of New York — New York, New York, United States
Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
Columbus Children's Hospital — Columbus, Ohio, United States
Children's Hospital of Oklahoma — Oklahoma City, Oklahoma, United States
Seattle Children's Hospital — Seattle, Washington, United States
Children's Hospital of Wisconsin — Milwaukee, Wisconsin, United States
University of Sao Paulo — São Paulo, Brazil

Full record on ClinicalTrials.gov

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