Systemic Lupus Erythematosus (SLE) / Triptorelin
Purpose
The purpose of this study is to test the safety of a drug called Triptorelin (Trelstar) when used for the protection of the ovaries during cyclophosphamide therapy for systemic lupus erythematosus (SLE).
Specifications
This is an intervention trial, which means it involves treatment (taking medicine). The study drug is given as an injection. The specifics of the study are:
- The study will take place at seven centers across U.S. (multicenter); 50 subjects total, approximately five to seven from Cincinnati Children's Hospital Medical Center.
- There are five study treatment groups. Four of the groups receive a specific dose of injectable Triptorelin that is based on body weight. One of the groups receives placebo (an inactive substance made to resemble the study drug) injections.
- You will be randomized into one of the five treatment groups. Randomization means you are put into a group completely by chance, like flipping a coin.
- This is a double-blind study, which means you and the study staff do not know which treatment group you are part of.
- There will be 23 study visits over 23 months.
Visit Procedures
At all visits include:
- Examination by a physician
- Evaluation for side effects and more study drug will be dispensed
- Questionnaires administered, subject diaries reviewed
At some visits:
- A blood sample will be taken through an arm vein, and will generally occur together with blood draws necessary for standard clinical care.
- Twelve hour urine collection
- Ultrasound of ovaries; this 45 minute painless procedure will happen at four study visits
- DEXA scan to measure bone density; this ten minute painless procedure will happen at three study visits.
- GnRH-Stimulation test (GAST); timed blood sampling over a 60 minute period through a butterfly needle; the GAST will happen three to six times during the study.
The length of each study visit will be different depending on which procedures are being done. Whenever possible, visits will be scheduled around the time you are coming to clinic or being admitted to the hospital to have your cyclophosphamide therapy.
Compensation in the form of a $15 gift certificate will be given for each completed study visit.
Contacts Us
For more information about this study, please contact Hermine Brunner, Principal Investigator, MD, MSc, Thomas Brent Graham or Shannen Nelson, Study Coordinator, 513-636-5484.
