Conditions: Systemic Lupus Erythematosus
Keywords: SLE Lupus Ovarian damage Menopause
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 31
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Triptorelin Pamoate 25 μg/kg body weight arm 2: Triptorelin Pamoate 50 μg/kg body weight arm 3: Triptorelin Pamoate 75 μg/kg body weight T3 arm 4: Triptorelin Pamoate 100 μg/kg body weight T4 arm 5: Normal Saline

Interventions: intervention 1: Triptorelin pamoate intervention 2: Triptorelin Pamoate intervention 3: Triptorelin Pamoate intervention 4: Triptorelin Pamoate intervention 5: placebo
Intervention descriptions: intervention 1: IM injection given monthly intervention 2: IM injection given monthly intervention 3: IM injection given monthly intervention 4: IM injection given monthly intervention 5: placebo 0.9% normal saline IM injection

Protocol document: