Repros Therapeutics Inc. (RPRX)'s New IND for the Investigation of Androxal(R) in the Treatment of Type II Diabetes in Men with Secondary Hypogonadism is Now Effective
2/2/2010 10:31:02 AM
THE WOODLANDS, Texas--(BUSINESS WIRE)--Repros Therapeutics Inc. (NasdaqCM:RPRX) today announced that the Company has received verbal confirmation from the Division of Metabolic and Endocrine Drug Products of the Food and Drug Agency that the Company may initiate its Investigational New Drug Application for the study of oral Androxal® in the treatment of hypogonadal men with Type II Diabetes (T2D) with a Phase IIa trial. The FDA noted no clinical hold issues but added that it may have some comments on the specifics of the Phase II design. Doses to be tested in the Phase IIa study have been safely tested for longer durations in trials in men for the treatment of secondary hypogonadism.