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

TherapeuticsMD Phase 1 Pilot Study Shows TX-12-004-HR Estradiol VagiCap Improves Conditions Of Vulvar And Vaginal Atrophy (VVA)

TherapeuticsMD, Inc. (NYSE MKT: TXMD), a women's healthcare company ("TherapeuticsMD" or the "Company"), announced today that its investigational drug, TX 12-004-HR estradiol VagiCap™, improved objective measures of VVA in a phase 1 clinical study. The study evaluated the efficacy and safety of a 10µg dose of TX 12-004-HR vs. placebo over a two-week period in 48 postmenopausal women with symptoms of VVA. Statistically significant differences were found between the treatment and placebo groups, with the treatment group showing changes in Maturation index (cell composition) and pH more closely resembling that found in premenopausal women with healthy, non-atrophied vaginal tissue.

Up to 50% of postmenopausal women are estimated to be affected by this condition which results from the decrease in estrogen that occurs with menopause. Despite symptoms that can adversely affect quality of life, sexual function, and urogynecologic health and include vaginal and vulvar pain, irritation, itching, burning, discharge, and painful intercourse, approximately 75% of women with symptoms do not seek treatment. The global market for postmenopausal VVA is currently estimated at over $1.6 billion and is projected to reach $3.1 billion by 2019.

TherapeuticsMD is developing TX 12-004-HR, its investigational drug for the treatment of VVA, for review by the U.S. Food and Drug Administration (FDA). TX 12-004-HR leverages the Company’s solubilized estradiol technology in a unique, tear-shaped softgel capsule designed for easy intravaginal insertion.

“VVA has a deleterious effect on a woman’s emotional and physical intimacy. As a company dedicated to meeting women’s health needs at every life stage, we are pleased that this phase 1 study suggests our investigational softgel capsule may offer a benefit. We are encouraged by the statistically significant improvements demonstrated here with our lowest dose and look forward to initiating a 12-week, phase 3 clinical trial to evaluate the efficacy of both 10µg and 25µg doses on the exact same measures evaluated in this trial,” said Julia Amadio, Chief Product Officer of TherapeuticsMD.

1 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