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 Reports Core 1-Year DEXA Study Fully Enrolled Ahead Of Schedule And Provides Update For Androxal(R) Clinical Program

  • Enrollment in DEXA study should ensure mid-2014 NDA submission
  • Pivotal studies recruiting on track or faster
  • Data project 83% of men with secondary hypogonadism will be successfully treated
  • No testosterone levels achieved beyond the normal range
  • Excellent benefit-risk ratio

THE WOODLANDS, Texas, Jan. 7, 2013 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc. ® (Nasdaq:RPRX) today provided a clinical update of its Androxal ® Phase 3 program.

1-Year DEXA Study

Critical path analysis showed that the DEXA study was key to an NDA submission. The Company is pleased to announce that the one year DEXA study is fully enrolled 3 months ahead of schedule. This key event should ensure the submission of the Androxal NDA by mid-2014. The Company plans to continue enrollment into the study to ensure that the FDA mandated long term safety requirements for a minimum exposure of 800 subjects for 6 months are met.

Pivotal Studies ZA-301 and ZA-302

Study ZA-301 has been fully enrolled for several weeks now with 8% of the subjects having completed the study. 3% of the subjects have dropped out before the first visit post the start of dosing. 146 subjects (randomized 3:1 active:placebo) have reached the 6 week visit at which time up-titration was allowed. 35% of the men in this blinded study have up-titrated. This is consistent with the fact that 25% of the subjects are on placebo and approximately 80% of men are projected to achieve normal testosterone levels on the 12.5 mg dose.

There have been no SAE's resulting in withdrawal from the study.

Though only a few sperm counts have been analyzed, men that achieve higher testosterone levels appear to exhibit increased sperm concentrations. This would be consistent with Androxal's action, which results in increased secretions of pituitary hormones that drive testicular function.

1 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
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!


DOW 17,826.30 -279.47 -1.54%
S&P 500 2,081.18 -23.81 -1.13%
NASDAQ 4,931.8150 -75.9760 -1.52%

Partners Compare Online Brokers

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs