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 Preliminary Findings: Second Pivotal Study And 6-Month Safety Study Support Androxal(R) Approvability

It is important to note that a detailed analysis of study ZA-301, and subsequently reported to the FDA, showed that unlike the suppression of FSH with approved testosterone, Androxal exhibits an increased frequency of sexual activity as determined by reported sexual abstinence. The reduced abstinence period resulted in lower sperm concentrations in some men on Androxal. These findings support those previously reported in the literature that show daily ejaculation results in sperm counts of <50% of baseline after only four successive days of sexual activity.

Study ZA-300 (Androxal Safety Study)

Of the 499 enrolled men, 409 completed the 6 month study. Twenty-eight men withdrew from the study due to adverse events, 8 due to lack of efficacy and the remaining 54 men due to lost to follow-up or procedural issues. The average age of men in the study was 49 with an average BMI of 33. The racial make-up the study was 74% Caucasian, 11% African American, 11% Hispanic, and 4% Other.

Over 50% of the men in the study ZA-300 achieved morning T's greater than 450 ng/dL. At the end of the study approximately 50% of the men were taking the higher 25 mg dose. Over 85% of men achieved testosterone levels within the normal range regardless of dose.

The majority of the recorded AE's were deemed mild to moderate in intensity. There was only one subject that developed an SAE that was deemed possibly related to drug. The subject developed a thromboembolism. He was hospitalized and recovered but exhibited multiple risk factors (BMI: 39, height: 6'5", race: African American, family history of DVT and lengthy recent travel) that may have spontaneously led to the event.

The most common AE's were related to upper respiratory tract infections (11.6%), but the study was conducted during the cold, flu and allergy season. Other AE's of note included headache (6.6%), muscle spasms (4%), and fatigue (2.8%). Transient blurred vision was noted in 1.4% but changes in visual acuity was noted as an adverse event in only 0.2%. These findings are in line with expectations given the average age of the subjects (approximately 49 years).

3 of 5

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 $93.74 0.00%
FB $117.58 0.00%
GOOG $693.01 0.00%
TSLA $240.76 0.00%
YHOO $36.60 0.00%


Chart of I:DJI
DOW 17,773.64 -57.12 -0.32%
S&P 500 2,065.30 -10.51 -0.51%
NASDAQ 4,775.3580 -29.9330 -0.62%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs