With the world population continuing its steep rise, a serious need exists to increase the contraceptive options for men. Present male contraceptive technology relies on the condom and vasectomy; methods that are not acceptable to many men for cultural or religious reasons. Although the """"""""male pill"""""""" may prove to be one solution for effective and reversible contraception when fully developed, there are likely to be many males who prefer non-hormonal products with fewer side effects. A silicone vas deferens device (the Intra Vas Device; IVD) has been under development for a number of years and has made considerable progress towards commercialization. The IVD has been designed to provide the same benefits as a vasectomy and be less traumatic, since IVD implantation does not require damaging the vas deferens to achieve vas obstruction. In addition, the IVD is expected to provide a simpler, faster and cheaper reversal procedure, compared to a vasectomy reversal. The IVD was shown to provide effective vas blockage in pilot clinical trials. IVD vas obstruction and complete recovery of sperm passage with IVD removal occurred in the primate. IVD safety was shown in two-year rat studies and in the pilot human studies. The advantages of the IVD over other vas devices tested previously (including silicone injected into the vas) are due to the IVD being preformed. IVD advantages include 1) it can be implanted and removed quickly by a relatively simple procedure, and 2) it can be fit to match the size of the vas lumen for better obstruction. Shepherd Medical has developed an improved IVD design in acute human studies and intends to perform all studies required to bring this refined IVD design to the market. The present project consists of two Specific Aims to ensure patient safety prior to human studies in Phase I1. The safety testing of this Phase I proposal includes: 1) in vitro evaluation of IVD sterilization methods prior to human implantation; and 2) in vitro evaluation of IVD mechanical performance with seven experiments. The successful outcome of this project will make human studies possible in Phase II.
