During the meeting with the FDA, male sexuality was mutually determined not to be appropriate as a clinical endpoint. As a result of the meeting, Repros plans to submit a new revised protocol focusing on endocrinological outcomes to the FDA.
Post study analysis of the population studied in a recently completed Androxal trial was consistent with men who had adult-onset idiopathic hypogonadotropic hypogonadism (AIHH). Men with AIHH are characterized as having both low testosterone and luteinizing hormone often accompanied by obesity and elevated blood glucose, among other signs. A retrospective analysis of results from this trial suggests that Androxal modifies the endocrinologic profile in terms of both hormones and glucose.
Joseph Podolski, president and CEO of Repros, stated: “I am encouraged by the openness of the discussions with the FDA regarding the possibilities of our future clinical development for Androxal. We believe Androxal may have the potential to reach a broader spectrum of endocrinological dysfunctions beyond the effects of low testosterone alone.”