This Day On The Street
Continue to site right-arrow
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
Stocks Under $10 with 50-100% upside potential - 14 days FREE!

Teva Women’s Health, Inc. Announces For The First Time Results Of Pivotal Phase III Study Of QuartetteTM (levonorgestrel/ethinyl Estradiol Tablets And Ethinyl Estradiol Tablets) At The 68th Annual Meeting Of ASRM

Stocks in this article: TEVA

Teva Women’s Health, Inc., a U.S.-based subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE: TEVA), today announced the findings from a Phase III pivotal trial of Quartette TM (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets), an investigational ascending-dose, extended-regimen oral contraceptive for the prevention of pregnancy that is currently under review by the U.S. Food and Drug Administration. These data were presented for the first time as a poster at the 68 th Annual Meeting of the American Society of Reproductive Medicine (ASRM).

The Phase III, multicenter, open-label, single arm study evaluated the efficacy and safety of Quartette TM over one year; 3,701 sexually active women 18 to 40 years old were enrolled and 2,144 completed the study. Data demonstrated Quartette TM is efficacious for the prevention of pregnancy and has a safety profile similar to that of other oral contraceptives. 1

“As a practicing OB/GYN, I continue to see women struggle with choosing an optimal contraceptive that fits their needs, so studying new contraceptive options with innovative designs is important,” said Dr. David J. Portman, MD, founder and principal investigator at the Columbus Center for Women’s Health Research, director of the Menopause Center of Columbus, clinical instructor at Ohio State University and an obstetrician/gynecologist with Portman OB/GYN. “The data presented at ASRM suggest that Quartette TM will be effective at preventing pregnancy.”

Quartette TM features a 91-day regimen, with an 84-day ascending ethinyl estradiol dose designed to minimize unscheduled or breakthrough bleeding, followed by period-stabilizing 10 mcg ethinyl estradiol pills during the traditional seven-day hormone-free interval.

Efficacy in the study was measured using the Pearl Index (PI) to report pregnancy rates. The PI was 2.92 (95% CI, 2.26-3.72), based on 65 pregnancies that occurred after the onset of treatment and within 7 days after the last combination tablet in women 18 to 35 years old, and excluding cycles in which another method of birth control was used. Adverse effects were similar to those seen with other oral contraceptives. The most common treatment-related adverse effects were metrorrhagia (5.9%) and headache (4.5%). i

“We are pleased to showcase these new data on a novel ascending-dose, extended regimen oral contraceptive for the prevention of pregnancy as part of the official ASRM program,” said Marty Berndt, vice president and general manager, US Brand Pharmaceuticals, Teva Women’s Health. “Quartette TM is an exciting advancement for women of reproductive age, as it offers them a unique contraceptive option. It also builds upon our heritage of providing women with innovative, extended-cycle contraceptive products, further reflecting our longtime commitment to women’s reproductive health.”

About Quartette™

Quartette™ is an investigational extended regimen combination oral contraceptive in development for the prevention of pregnancy. Each 91-day cycle consists of ethinyl estradiol 20/ levonorgestrel 150 mcg for 42 days, ethinyl estradiol 25/ levonorgestrel 150 mcg for 21 days, ethinyl estradiol 30/ levonorgestrel 150 mcg for 21 days, and ethinyl estradiol 10 mcg for 7 days.

1 of 3

Select the service that is right for you!

Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

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
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

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

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, 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
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
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 17,804.80 +26.65 0.15%
S&P 500 2,070.65 +9.42 0.46%
NASDAQ 4,765.38 +16.9840 0.36%

Brokerage Partners

Rates from

  • Mortgage
  • Credit Cards
  • Auto

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs