Safety, and acceptability of a non-hormonal vaginal ring

Modern contraceptives not only play a critical role in preventing unplanned pregnancy but also contribute to a woman s well being by empowering her with the necessary resources to control her own reproductive healthHowevercurrently available female contraceptives are lacking in one or more important parametersincluding effectivenesssafetyand usabilitythus rendering the currently available contraceptive mix sub optimalA high impact driver of the growing contraceptives market is the number of unintended pregnanciesthe risk of which is increased when contraceptives are used incorrectlyinconsistentlyor not at allApproximatelymillion unintended pregnancies were reported in the US inposing a significant medical risk for mothers and childrenand placing significant economic burdens on individual women and the general publicImperfect use of currently available contraceptive options can be attributed to a range of obstaclesincluding inconveniencedaily actionor action at the time of intercourseand adverse side effects associated with hormonal contraceptivesThese drawbacks demonstrate a need for novelnon hormonal contraceptive options that are convenienteasy to useand effectiveTo meet this needDarBioscienceIncis developing the Ovaprenedevicea non hormonal intravaginal ring that provides a safe and effective monthly birth control optionOvaprene combines a flexible mesh barrier that covers the cervix while slowly releasing a mix of non hormonalspermiostatic ingredientsThe FDA has already designated Ovaprene as a combination product and determined that the Center for Devices and Radiological HealthCDRHwill be the lead reviewing agency for this novel contraceptiveThe objective of this SBIR proposal is to demonstrate the preliminary contraceptive performancesafetyactive agent release profileacceptanceand fit of Ovaprene in a single centeropen labelnon significant risk device studyPreliminary efficacy will be evaluated by postcoital testing and the measurement of any progressively motile sperm gaining access to the cervix in women wearing the Ovaprene deviceSafety will be evaluated overdays of continuous useWe will also establish post production quality control metrics and collect agent release dataThe successful accomplishment of all milestones in this proposal will provide necessary information to support a Pivotal efficacy human study of Ovaprene contraceptive effectiveness in advance of FDA clearance for the US market Side effectscontraindications and lifestyle choices limit the use of hormonal contraceptive agents for many womenThe availability of a non hormonalmonthlysafeeffective and easily reversible contraceptive option will be an important advance in expanding contraceptive options available to couplesThis SBIR proposal aims to implement a clinical trial to demonstrate the preliminary efficacysafetyrelease profileacceptabilityand fit of Ovaprenea non hormonal intravaginal ring contraceptive deviceSuccessful completion of this work will result in further trials designed to demonstrate safety and contraceptive effectiveness necessary for FDA approval and manufacture of Ovaprene for widespread use