This Day On The Street
Continue to site
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

Repros Provides Clinical Update For Androxal(R) Phase 3 Program

The study is being conducted at various US clinical sites. As of this date 158 men have been enrolled in ZA-300 and 62 men have completed 6 weeks of treatment at the 12.5 mg dose.

In general, the population of men studied in ZA-300 is identical to the population in the pivotal studies with the exception that they may be current testosterone users who have refrained from testosterone use for an appropriate wash out period and there is no sperm count entry requirement.

Repros Believes Early Results from ZA-300 May Be Predictive of Positive Outcome for Pivotal Studies

For the first 62 men that have completed dosing at the lower 12.5 mg dose, 80.6% of men have exhibited testosterone levels above 300 ng/dL after 6 weeks of treatment which exceeds the pivotal study criteria for success. None of the men have exhibited testosterone levels outside of the normal range. The mean testosterone level at baseline was 206 ng/dL and at the end of the 6 weeks the mean rose to 428 ng/dL (pairwise comparison of week 6 results to baseline yielded a p value of < 0.00001). This data is in line with previous Repros Androxal studies. The Company believes many of the men that did not achieve a testosterone level of 300 ng/dL will experience an improvement when they up-titrate to the 25 mg dose. The Company plans to update the findings from the ZA-300 study as warranted by the data.

One Year DEXA Study (ZA-303)

The Company has also begun enrollment in the one year DEXA study to determine effects of Androxal on bone mineral density. The study is being conducted at various US sites. Repros believes that Androxal will have no negative impact on bone and previous studies have shown improvement in markers of bone turnover.

The ZA-303 study, due to its duration, is on the NDA critical path. Depending on recruitment into this study, the Company currently believes it can submit the NDA during the first half of 2014.

2 of 3

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free
AAPL $94.02 0.00%
FB $104.07 0.00%
GOOG $683.57 0.00%
TSLA $162.60 0.00%
YHOO $27.97 0.00%


Chart of I:DJI
DOW 16,204.97 -211.61 -1.29%
S&P 500 1,880.05 -35.40 -1.85%
NASDAQ 4,363.1440 -146.4150 -3.25%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs