This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Long-term goal of this application is to develop therapies for protecting the gonadal function of children with SLE through therapeutic interventions whose beneficial effects have been verified by high-quality clinical evidence. The expected results of the current application are to determine the safety of triptorelin, its dose and the time necessary to achieve complete ovarian suppression (COS) prior to chemotherapy, as well as obtain preliminary evidence of its efficacy to provide ovarian protection for young females with SLE. The central hypothesis of this application is that triptorelin can safely achieve COS and may effectively preserve ovarian function of adolescent females with SLE requiring gonadotoxic chemotherapy with cyclophosphamide (CYT). We have formulated this hypothesis based on the results of supportive studies in adult patients with SLE 6. The rationale that underlies the investigation is that identification of more effective interventions to preserve ovarian function and avoid premature menopause will translate into increased fertility, fewer risk factors of cardiovascular disease, osteoporosis and other long-term health complications of menopause and by this lower the overall societal costs associated with SLE. Fifty adolescent females with SLE newly requiring CYT will be recruited from 7 sites over a period of 12 months and randomized to receiving during chemotherapy either triptorelin or placebo. The age of subjects will be approximately 9-21 year, as only females who have entered puberty will be eligible for treatment with the study medication. Participants will receive study treatment for up to 23 months. The general study design is a Phase I/II, double-blinded placebo controlled randomized clinical trial. Participants will be randomized in a 4:1 fashion to receive either study drug (triptorelin) or placebo (normal saline).
Showing the most recent 10 out of 563 publications
