SBIR-STTR Award

We plan to develop an effective custom-molded contraceptive cervical cap for intermenstrual use. It would aim to offer a new female barrier method of contraception with a lower pregnancy rate, a longer period of continuous use, better protection against some sexually transmittable infections, and less need for user compliance than those currently available. Although the only previous custom-fitted cap, "Contracap", encountered excessive dislodgements and pregnancies, it proved beyond a doubt that custom-fitted caps can be worn for months without adverse effects. While preliminary results suggest that a custom-molded cervical cap might provide a means of long-term wear without dislodgement, further refinement of procedures is needed. In order to develop an effective custom-molded contraceptive cervical cap for intermenstrual use, we will pursue the following three aims: (1) to explore, improve, and simplify methods of taking cervical impressions in an effort to develop the custom-molded cap, (2) to research, test, and develop specific changes in cap materials and design aimed at improving retention and efficacy, and (3) to test caps for safety, stability, and acceptability, but not for contraception.Awardee's statement of the potential commercial applications of the research:The need for, and concern about, both birth control and protection from the epidemic of venereal infections is growing throughout the world. If an effective long-term cervical cap could be individually molded in a quick and simple process, it might well meet both of these needs and take over a significant share of the contraceptive market.National Institute of Child Health and Human Development (NICHD)

An innovative approach to barrier contraception will be developed 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 intermenstrual 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.Awardee's statement of the potential commercial applieations of the research:Our objective is to produce a much more competent barrier method of contraception; a custom-fitted user-friendly cervical cover or cap for extended continuous use with a lower failure rate and the potential of reducing the risk of sexually transmittable infections. There is clearly a great and growing need for such a device and an extensive prospective market.National Institute of Child Health and Human Development (NICHD)