An intravaginal contraceptive device for the delivery of an acrosin and hyaluronidase inhibitor.

A study was begun to develop a contraceptive delivery system that would free the user from precoital or daily administration and utilize a nonhormonal agent as the active ingredient. Testing of such a system in rabbits has led to the development of a device that will release a controlled level of an acrosin and hyaluronidase inhibitor into the vagina. This toroidal device is composed of a core of tetradecyl sodium sulfate (TDSS) incorporated in polyurethane surrounded by a rate-limiting membrane of polyurethane. Such devices had a sustained in vitro TDSS release rate of greater than or equal to 400 micrograms/day for over 30 days. These devices had a complete contraceptive effect in 15 rabbits bred weekly for 4 weeks. The contraceptive effect is due to release of the TDSS into the vagina and the subsequent binding of the TDSS to spermatozoa in the female reproductive tract. TDSS has a very low toxicity profile in the rat, dog, and rabbit.