MULTIPHASIC RELEASE OF LHRH FOR TREATING INFERTILITY

MAINTENANCE OF SEXUAL MATURITY DEPENDS UPON COMPLEX ENDOCRINE COMMUNICATION BETWEEN THE CENTRAL NERVOUS SYSTEM, ANTERIOR PITUITARY GLAND, AND GONADS. APPROXIMATELY 20 PERCENT OF THE MARRIED COUPLES IN THE UNITED STATES EXPERIENCE SOME FORM OF INFERTILITY. IN MANY CASES, THE CAUSE OF AN INFERTILE STATE IS DUE TO INADEQUATE OR INAPPROPRIATE INTERACTION BETWEEN THE BRAIN AND PITUITARY GLAND. INFERTILITY THAT IS THE RESULT OF INADEQUATE PITUITARY STIMULATION BY LUTEINIZING HORMONE-RELEASING HORMONE (LHRH) CAN BE REVERSED BY ADMINISTRATION OF EXOGENOUS LHRH. HOWEVER, LHRH ADMINISTRATION MUST BE IN A PULSED FASHION, AND PRESENT PROTOCOLS RELY ON I.V. LHRH DOSING USING INFUSION PUMPS FOR INTERMITTENT DELIVERY. WHILE THE RESULTSCAN BE ENCOURAGING, THE PATIENT'S LIFE STYLE IS SERIOUSLY COMPROMISED DURING THERAPY. THIS RESEARCH PROGRAM FOCUSES ON THE DEVELOPMENT OF AN IMPLANTABLE DELIVERY SYSTEM FOR INFERTILITY TREATMENT. THISSYSTEM RELIES ON A BIODEGRADABLE IMPLANT DESIGNED TO DELIVERLHRH IN PULSES. NO EXTERNAL MANIPULATION IS REQUIRED FOR LHRH RELEASE, AND NO INVASIVE PROCEDURES ARE NEEDED FOR REMOVAL OF THE IMPLANT. ADDITIONALLY, DEVELOPMENT OF THIS RELEASE TECHNOLOGY WILL IMPACT UPON OTHER TREATMENT REGIMES REQUIRING PULSED RELEASE OF AN ACTIVE BIOLOGICAL.