Triptorelin for Ovary Protection in Childhood Onset Lupus
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Diagnostic
- To determine the dose of triptorelin that will maintain complete ovarian suppression between monthly injections [ Time Frame: Patients receive injections every 23-29 days ] [ Designated as safety issue: No ]Patients will receive monthly injections. Exact date and time is recorded. Information will be analyzed to determine length of suppression between injections
- To optimize the time interval at triptorelin injection and infusion of cyclophosphamide [ Time Frame: Monthly ] [ Designated as safety issue: No ]Data will be analyzed to determine best time to give triptorelin injection during cytoxan therapy.
|Study Start Date:||June 2003|
|Estimated Study Completion Date:||September 2014|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Experimental: Triptorelin Vs Placebo (Normal Saline)
Placebo (Normal Saline) vs triptorelin Pamoate
Drug: Triptorelin pamoate
IM injection given monthly
Other Name: Trelstar Depot
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.
|United States, California|
|Children's Hospital of Los Angeles|
|Los Angeles, California, United States, 90027|
|United States, Illinois|
|Children's Memorial Hospital|
|Chicago, Illinois, United States, 60614|
|United States, New Jersey|
|Hackensack University Medical Center|
|Hackensack, New Jersey, United States, 07601|
|United States, New York|
|Morgan Stanley Children's Hospital of New York|
|New York, New York, United States, 10032|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|Columbus Children's Hospital|
|Columbus, Ohio, United States, 43205|
|United States, Oklahoma|
|Children's Hospital of Oklahoma|
|Oklahoma City, Oklahoma, United States, 73104|
|United States, Washington|
|Seattle Children's Hospital|
|Seattle, Washington, United States, 98105|
|United States, Wisconsin|
|Children's Hospital of Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|University of San Paulo|
|San Paulo, Brazil|
|Principal Investigator:||Hermine I Brunner, M.D. M.Sc.||Children's Hospital Medical Center, Cincinnati|