CLINICAL EVALUATION OF NEW CHEMICAL CONTRACEPTIVES FOR MEN

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Conduct a Phase I clinicfal trial to test new compounds such as 11-beta methyl nortestoserone dodecylcarbonate will be well tolerated and suppress gonadotrophins as a contraceptive drug for men. Clinical Evaluation of New Chemical Entities for Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics for Use as Contraceptives in Healthy Men The objective of the task is to evaluate via Phase I clinical studies, whether doses of new chemical entities such as 11-beta methyl nortestosterone dodecylcarbonate, will be safe and well tolerated. Results from initial Phase I studies will establish if the agent could be evaluated in longer-term clinical trials pursuant to obtaining FDA approval as a contraceptive. Therefore, the objective of this Task Order is to conduct clinical evaluation so that the overall objectives of the Phase I clinical studies are successfully achieved.