Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Repros Therapeutics plans to submit a revised trial protocol to the FDA for its secondary hypogonadism treatment Androxal after a meeting with the agency.
Subscribe to our email newsletter
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.”