Multipurpose Device for Female-initiated Nonsteroidal On-Demand Contraception

PROJECT SUMMARY/ABSTRACT The challenge of the future is to develop innovative, female-initiated contraceptive technologies that are afford- able, socially acceptable, and provide desired protection from unintended pregnancy without exposing women to additional health risks associated with systemic distribution of contraceptive hormones. Our preliminary data demonstrate discovery of drug-free, bioresponsive polymer compositions that dramatically increase in viscosity upon exposure to semen, thereby effectively preventing pregnancy in vivo. In an expansion of this pioneering SMART (= System Mute until Activation by a Remote Trigger) polymer concept, we propose a novel delivery technology using an on-demand dual-compartment vaginal device that enables women to fortify the nat- ural contraceptive barriers at the cervicovaginal junction without pharmacological action of drug mole- cules. This high-risk/high-reward research strategy is fundamentally different from conventional nonsteroidal contraceptive methods as it represents a drug-free bioengineering approach intended to reach the human testing phase (i.e., IDE milestone for medical devices) much faster and at a lower cost than conventional development programs focusing on pharmacologically active agents. For this study, it is hypothesized that development of a multipurpose device enables women to accurately deposit a small dose of a fabric-like, polymeric SMART fiber mats intravaginally and, simultaneously, administer supplemental fluid to accelerate reconstitution of a biore- sponsive, acid-buffering, and mucoadhesive SMART gel phase that fortifies the natural contraceptive physical and chemical barrier properties at the cervicovaginal junction. In Aim #1, we will design a dual-compartment device for female-controlled intravaginal administration of contraceptive SMART fiber mats and fabricate proto- type devices for in vitro testing of critical device performance characteristics. In Aim #2, we will conduct bench testing of dual-compartment device prototypes in vitro to evaluate fiber insertion and SMART gel formation. In Aim #3, we will solicit feedback from women on acceptability and end user desirability of different prototype devices using focus group discussions to define human factors contributing to use-related safety and efficacy risks of the multipurpose device designed for female-initiated vaginal delivery of contraceptive SMART fiber mats. Finally, we will assess performance, safety, and efficacy of the optimized multipurpose device for vaginal delivery of contraceptive SMART fiber mats in vivo using the sheep model (Specific Aim #4).