Triptorelin for Ovary Protection in Childhood Onset Lupus
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 2

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
    

Detailed description: 
      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.
    

Intervention name(s): Triptorelin pamoate; Triptorelin Pamoate; Triptorelin Pamoate; Triptorelin Pamoate; placebo
Intervention type(s): Drug; Drug; Drug; Drug; Other
Intervention description(s): IM injection given monthly; IM injection given monthly; IM injection given monthly; IM injection given monthly; placebo 0.9% normal saline IM injection
Other intervention name(s): Trelstar Depot; Trelstar Depot; Trelstar Depot; Trelstar Depot; placebo 0.9% normal saline
Intervention MeSH terms: Triptorelin Pamoate
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Diagnostic
Keywords: SLE; Lupus; Ovarian damage; Menopause