. This is a Phase II proposal for design, production, and a two part clinical test for a estrogen/progestin patch for menopausal administration to reduce risks of osteoporosis. During Phase I and in a separate NICHD supported project a contraceptive patch was developed which can effectively coadminister levonorgestrel and estradiol. At the present time no estrogen-progestin patch is commercially available. BIOTEK proposes to use its existing and proven technology to develop a dual-hormone patch. Phase II will design production equipment, prepare and characterize cGMP samples, study stability, submit an IND, conduct a two part clinical test, analyze and report the clinical data to the FDA, and seek a commercial partner for this promising new product.
