Synthesize sufficient quantities of the LHRH antagonist for pharmaceutical (preformulation/formulation studies) and preclinical/clinical studies. Conduct necessary pharmacology, toxicology, quality control studies on the LHRH antagonist as required by FDA for approval of proposed clinical studies under an IND. Find an IND to cover proposed clinical studies. Conduct clinical studies aimed at: demonstrating the antiovulatory potential of the LHRH antagonist in the female; studying the utility of the LHRH antagonist as an inducer of luteal dysfunction when administered during the first two to three days of the cycle; and demonstrating the antispermatogenic potential of the LHRH antagonist.
| Adams, L A; Bremner, W J; Nestor Jr, J J et al. (1986) Suppression of plasma gonadotropins and testosterone in adult male monkeys (Macaca fascicularis) by a potent inhibitory analog of gonadotropin-releasing hormone. J Clin Endocrinol Metab 62:58-63 |
