As part of Dr. Orlando’s analyses he also looked at the impact of Androxal and Androgel on luteinizing hormone (LH) and follicle stimulating hormone (FSH) in the men with baseline morning testosterone ≤ 250 ng/dl. Androxal significantly increased LH levels in a dose dependent manner. LH stimulates the testes to produce testosterone. Androxal also significantly increased FSH in a dose dependent manner. FSH stimulates the testes to produce sperm. He further determined that there was a statistically significant correlation between changes in LH and changes in morning testosterone level (correlation = 0.6137, p value <0.0001). This analysis underscores the mode of action of Androxal which restores pituitary responsiveness to low circulating levels of testosterone, in turn stimulating the testes to produce normal levels of testosterone in a normal rhythmic pattern.Conversely, Androgel significantly reduced pituitary secretions of both LH and FSH which further suppressed testicular function, and causes variability in testosterone levels not corresponding to the normal rhythmic pattern observed in healthy males. One of the safety assessments proposed by the FDA that will be made in the planned Phase IIb study is to assess the impact of Androxal compared to placebo and Testim (an approved topical testosterone preparation) upon the reproductive status of men receiving three months of treatment with the study drugs. Dr. Orlando also observed that over 62% of men on Androgel in the analysis of the 003 study exhibited FSH levels below the lower limit of normal (1.4 mIU/ml) after three months of Androgel treatment, and noted that over 43% of those men had FSH levels below the lower limit of detection 0.3 mIU/ml. In a previous proof of principle study conducted by Repros it was found that roughly 80% of men with FSH levels less than 2.0 exhibited sperm parameters that would be considered sub fertile. After three months of treatment all men on the 25 mg dose of Androxal had FSH levels above 1.4 mIU/ml (minimum observed 2.9).
Joseph S. Podolski, President and CEO of Repros, commented, “We believe Dr. Orlando’s observations bode well for our upcoming Phase IIb study and further reinforce the findings from our previous studies.” He further stated, “Unlike testosterone replacement therapy, Androxal treats the underlying defect that is the reason for low testosterone levels in the majority of men that experience this condition. Androxal normalizes testicular function, improving testosterone levels back into the normal range, and maintains a man’s reproductive status.”About Repros Therapeutics Inc. Repros Therapeutics focuses on the development of oral small molecule drugs for major unmet medical needs that treat male and female reproductive disorders. Any statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties, including Repros' ability to have success in its clinical trial programs, raise needed additional capital on a timely basis in order for it to continue to fund its operations and pursue its development activities, and such other risks which are identified in the Company's most recent Annual Report on Form 10-K and in any subsequent quarterly reports on Form 10-Q. These documents are available on request from Repros Therapeutics or at www.sec.gov . Repros disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. For more information, please visit the Company's website at http://www.reprosrx.com.