The 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statins) are widely used for the treatment of hyperlipidemia, and recent in vitro and animal data suggest that statins promote bone formation and increase bone strength. We examined the relationship between sustained continuous delivery of statin and fracture healing rates in adult male animals with femoral segmental fractures. Because statin affects the production of cholesterol we also evaluated the influence of statin, on adrenal and testicular steroidogenesis and the morphology of the reproductive tract tissues in animals receiving statin for a period of 12 weeks post surgery. Simvastatin significantly increased fracture healing and without significant influence on the body weights and the weights of the reproductive organs. Basal plasma LH, FSH and testosterone levels were not affected by active treatment with simvastatin. Reproductive tissue morphology was unchanged by local sustained release of statin. In conclusion, long-term simvastatin treatment delivered at a fracture target site did not influence testicular reproductive and endocrine function, but was able to effectively heal complicated segmental fracture. Copyright 2005 ISA. All Rights Reserved.