Hypogonadism Associated with Metabolic Syndrome/ Secondary Hypogonadism and AIHH
We intend to initiate a Phase 2b proof-of-concept clinical trial in men with low testosterone and adult-onset idiopathic hypogonadotrophic hypogonadism, or AIHH, with concomitant plasma glucose and lipid elevations, all of which are components of metabolic syndrome. This study will be initiated following a meeting we plan to have with the FDA after their response to certain documents we have submitted to them.
Estimated Market Size
- Approximately 20% of the male population experiences conditions associated with Metabolic Syndrome.
- Incidence rate increases with age.
- Increasing incidence of obesity and Type II diabetes over last 20 years.
- More than 32 million men in the U.S. have Metabolic Syndrome.
Current Standard of Care
First line therapy is a therapeutic change in lifestyle.
- Increased physical activity
- Anti-atherogenic diet
- Weight loss
Drug therapy is employed when lifestyle changes are insufficient. Each component of Metabolic Syndrome is treated independently.
- Dyslipidemia (triglycerides > 150mg/dL or HDL < 40mg/dL)
- Statins
- Fiber
- Niacin
- Obesity (waist circumference > 40")
- Xenical®
- Acomplia®
- Meridia®
- Hypertension (BP > 130/85mm Hg)
- ACE inhibitors
- Diuretics
- Diabetes (fasting glucose > 100mg/dL)
- Insulin
- Glucose lowering agents
Key Data Collected to Date
- A retrospective review of clinical data from our 200 patient non-pivotal U.S. Phase 3 clinical trial, showed that Androxal therapy resulted in a significant reduction in mean glucose levels in men with a body mass index, (BMI) >26 and glucose levels >104 mg/dL, an outcome not seen in the placebo or AndroGel® arms of this study.