THE APPLICATION'S LONG-TERM OBJECTIVE IS TO DEVELOP A MORE EFFECTIVE, SAFE, RELATIVELY LONG-TERM BARRIER CONTRACEPTIVE DEVICE.

THE APPLICATION'S LONG-TERM OBJECTIVE IS TO DEVELOP A MORE EFFECTIVE, SAFE, RELATIVELY LONG-TERM BARRIER CONTRACEPTIVE DEVICE. DEVELOPMENT OF THE PROPOSED DEVICE WILL HAVE SIGNIFICANT IMPACT ON EFFECTIVE CONTROL OF OVERPOPULATION AND REDUCTION OF ABORTIONS SECONDARY TO UNWANTED PREGNANCIES. THE APPLICANTS' SPECIFIC AIMS ARE 1. TO DEVELOP A POLYMER MATRIX SYSTEM IN WHICH AN IMPROVED CONTRACEPTIVE AGENT IS INCORPORATED; AND 2. TO DETERMINE PHYSICAL AND CHEMICAL PROPERTIES OF THE DEVICE WHICH WILL ALLOW FOR THE LONG-TERM RELEASE OF SUFFICIENT AGENT THAT WILL RENDER THE DEVICE CONTRACEPTIVELY EFFICACIOUS. THESE AIMS WILL BE MET BY INCORPORATING AN ACTIVE AGENT (L-21985) WITH KNOWN CONTRACEPTIVE EFFICACY AND LOW TOXICITY INTO A COPOLYMER MATRIX. RELEASE OF L-21985 FROM THE MATRIX WILL BE QUANTIFIED BY ENZYMIC ASSAY. RELEASE RATES WILL BE OPTIMIZED BY VARYING THE MONOMER RATIO OF THE COPOLYMER MATRIX, THE PARTICLE SIZE OF THE ACTIVE AGENT INCORPORATED INTO THE MATRIX, AND THE PERCENT LOADING OF THE ACTIVE AGENT INTO THE MATRIX. OPTIMIZATION OF THESE VARIABLES TO PRODUCE A COMPOSITE DEVICE WHICH RELEASES CONTRACEPTIVE LEVELS OF L-21985 FOR PERIODS UP TO 14 DAYS WILL REPRESENT THE SUCCESSFUL COMPLETION OF PHASE I. THIS END POINT IS PREREQUISITE TO PHASE II OBJECTIVES OF 1. INCORPORATING THE POLYMER MATRIX INTO AN EXISTING BARRIER-TYPE CONTRACEPTIVE DEVICE (E.G., VAGINAL RING, CERVICAL CAP); AND 2. EVALUATING THE COMPOSITE DEVICE IN PHASE I CLINICAL TRIALS. THE PROPOSED PROJECT WILL LEAD TO THE DEVELOPMENT OF A SAFE, HIGHLY EFFECTIVE, RELATIVELY LONG-LASTING, EASY-TO-USE CONTRACEPTIVE DEVICE. THESE ATTRIBUTES ARE CLEARLY COMPATIBLE WITH A PRODUCT WITH HIGH MARKET POTENTIAL.