Overall, the population entered this study with significant comorbidities. Approximately 20% had type 2 diabetes, 37% were diagnosed with hypertension and 70% had a BMI over 30. Approximately 79% had a significant risk factor for cardiovascular disease. Taking these facts into consideration, Androxal was generally well tolerated.Also, with approximately 50% of subjects up-titrated to the higher dose, it is remarkable that there was no dose response noted in the incidence of adverse events. If anything, adverse events of note could have easily been attributed to raising of testosterone or just general age effects. For example 7.4% of subjects exhibited an elevation in PSA of 0.75 ng/ml or more. This is consistent with the experience reported for Androgel ®. As men were followed for two months after treatment, those men that experienced an increase in PSA generally returned to baseline levels as their T receded.
Repros Reports Preliminary Findings: Second Pivotal Study And 6-Month Safety Study Support Androxal(R) Approvability
Check Out Our Best Services for Investors
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Model portfolio
- Stocks trading below $10
- Intraday trade alerts
More than 30 investing pros with skin in the game give you actionable insight and investment ideas.