BIOTEK has developed a sustained release bioerodible contraceptive spermicide suppository which delivers spermicide over a period of 12-16 hours in vitro. The composite suppository has been extensively tested in vitro and its safety confirmed in vivo in rabbit vaginal irritation tests. It has been approved by the FDA for Phase I clinical trials. Before such trials can be performed, however, the duration of efficacy of the suppository should be evaluated in animals. During Phase I the formulation was optimized to achieve maximum duration of efficacy in vitro. The new formulation was also tested in vivo and was able to reduce the fertilization rate of rabbits from 92% to less than 6% for a period of 12 hours. Support is sought for a 2 year Phase II period to complete testing the duration of efficacy of the suppository in animals and to proceed with human clinical trials.
