Secondary Hypogonadism with Male Fertility Maintenance & Improvement
During the second quarter of 2008, we initiated a Phase 2b proof-of-concept Androxal clinical trial in men of reproductive age with low testosterone levels who want to improve or maintain their fertility and/or sperm function while being treated for low testosterone. This trial includes a control group that will be given Testim®, a popular testosterone replacement therapy. We intend to have an End of Phase 2 Meeting with the Food and Drug Administration, or FDA, in the second half of 2009.
Estimated Market Size
- Recent estimates show that approximately 13 million men in the United States experience testosterone deficiency.
- Of the 13 million, approximately 70% or 9.1 million have secondary hypogonadism.
- While this condition is more prevalent in older men, of the 9.1 million, approximately 33% are under the age of 50 and may be interested in maintaining or enhancing their fertility while receiving therapy for low testosterone.
- The current worldwide testosterone replacement market is approximately $750 million. We estimate the market for fertility maintenance to be approximately $250 million.
Current Standard of Care
- Hormone therapy
- Exogenous testosterone
- Androgens
Key Data Collected to Date
- One-year, open label safety study of Androxal for the treatment of male secondary hypogonadism. We believe safety data derived from this study will be applicable for this new indication of Androxal.