Triptorelin for Ovary Protection in Childhood Onset Lupus
Status:
Completed
Trial end date:
2014-03-01
Target enrollment:
Participant gender:
Summary
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