An innovative approach to barrier contraception is proposed based on a valve-less custom-fitted cervical cap design developed during preliminary Phase I feasibility studies. The device is fabricated from silicone rubber using a simple molding method. This novel barrier contraceptive can be worn continuously during the inter-menstrual period. Limited preliminary post-coital tests conducted during Phase I indicated device efficacy in the prevention of sperm entry into cervical mucous. It is proposed that, during Phase II, further post-coital tests be conducted to finalize design selection and fabrication methodology in preparation for F.D.A. Phase II efficacy testing. If post-coital testing is successful, attempts will be made to develop a valved cervical cap to allow exit of menstrual flow, yet prevent sperm entrance into the cervix. The modified valved contraceptive would enable continuous wearing of the device.
