Secondary hypogonadism is the most common cause of low testosterone amongst American males. Unlike the topical creams and gels Androxal does not suppress pituitary secretions of LH and FSH (follicle stimulating hormone). Topical testosterone suppresses fertility. Androxal enhances production of both testosterone and sperm. Unlike approved topical testosterone treatments, unwanted transfer of testosterone to women and children is not possible. Since, in the case of Androxal, pituitary regulation is still intact, supernormal levels of testosterone are not achieved. In an exploratory efficacy and safety study in Androxal conducted in 2009, Repros showed that Androxal restores normal sperm counts while increasing testosterone levels in hypogonadal men.

On Monday, August 9, 2010, Repros announced that the FDA agreed with the Company's proposal to conduct two Phase III placebo and active controlled studies in order to demonstrate the benefit of Androxal in normalizing testosterone levels while preserving fertility.

Source Repros Therapeutics Inc.