Secondary Hypogonadism with Male Fertility Maintenance & Improvement
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
- Current ongoing 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.
Next Steps
- In the second quarter of 2008, we will initiate a small Phase 2b proof of concept study to elucidate Androxal's effect on fertility and we anticipate providing data from this clinical trial in the second quarter of 2009.
- With successful results from this proposed Phase 2b clinical trial and preclinical studies and upon acceptance by the FDA, we intend to initiate Phase 3 clinical trials for this indication in the third quarter of 2009.