Male Fertility Maintenance & Improvement
During the second quarter of 2008, we initiated a Phase 2b proof-of-concept clinical trial (ZA-201) 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 included a control group that will be given Testim®, a popular testosterone replacement therapy. On October 6, 2009 we announced that Androxal® was able to maintain sperm counts in men being treated for their low testosterone levels. Testim® resulted in suppressed sperm levels while men were being treated with that topical gel.
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.
Eight-month, Open-Label, Phase IIB Study to Evaluate Fertility in Men with Secondary Hypogonadism, Comparing Androxal® to a Topical Testosterone in Men Previously Treated with Topical Testosterone. Androxal® was able to maintain sperm counts in men being treated for their low testosterone levels.