In this study, dyspareunia was the most bothersome symptom at baseline (57%) followed by vaginal dryness, itching and burning.()Unlike hot flashes or night sweats, signs and symptoms of vaginal atrophy have been shown to increase over time in postmenopausal women.
Study Design and Results:
At week 12, improvements in VMI and vaginal pH with daily and twice-weekly use of PREMARIN Vaginal Cream 0.5 g were significantly greater relative to placebo (P<0.001). Results from the 12-week phase also showed that both low-dose regimens of PREMARIN Vaginal Cream (0.5 g daily and twice weekly) significantly improved the most bothersome symptoms score versus placebo at 12 weeks (P less than or equal to 0.001), including those for dyspareunia (P less than or equal to 0.01).
About PREMARIN Vaginal Cream
Important Safety Information:
PREMARIN((R) )(conjugated estrogens) Vaginal Cream is used after menopause to treat menopausal changes in and around the vagina and to treat painful intercourse caused by menopausal changes of the vagina.
The most commonly reported side effects of PREMARIN Vaginal Cream include headache, infection, abdominal pain, accidental injury, and vaginitis.
Women produce less estrogen after menopause. When estrogen levels begin dropping, vaginal walls become thinner and less lubricated, and some women experience vulvar and vaginal atrophy. Vulvar and vaginal atrophy can result in vaginal irritation, dryness, dyspareunia (painful sexual intercourse), discharge and bleeding after sex.
Dyspareunia, or pain experienced during sexual intercourse, can be a bothersome symptom of vulvar and vaginal atrophy. Based on a survey of 200 women transitioning through menopause, approximately one in three reported experiencing dyspareunia. Dyspareunia typically does not subside without treatment.
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women’s health care, infectious disease, gastrointestinal health, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products.
The statements in this press release that are not historical facts are forward-looking statements that are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, among others, risks related to our proposed merger with Pfizer, including satisfaction of the conditions of the proposed merger on the proposed timeframe or at all, contractual restrictions on the conduct of our business included in the merger agreement, and the potential for loss of key personnel, disruption in key business activities or any impact on our relationships with third parties as a result of the announcement of the proposed merger; the inherent uncertainty of the timing and success of, and expense associated with, research, development, regulatory approval and commercialization of our products and pipeline products; government cost-containment initiatives; restrictions on third-party payments for our products; substantial competition in our industry, including from branded and generic products; emerging data on our products and pipeline products; the importance of strong performance from our principal products and our anticipated new product introductions; the highly regulated nature of our business; product liability, intellectual property and other litigation risks and environmental liabilities; the outcome of government investigations; uncertainty regarding our intellectual property rights and those of others; difficulties associated with, and regulatory compliance with respect to, manufacturing of our products; risks associated with our strategic relationships; global economic conditions; interest and currency exchange rate fluctuations and volatility in the credit and financial markets; changes in generally accepted accounting principles; trade buying patterns; the impact of legislation and regulatory compliance; risks and uncertainties associated with global operations and sales; and other risks and uncertainties, including those detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including our current reports on Form 8-K, quarterly reports on Form 10-Q and annual report on Form 10-K, particularly the discussion under the caption “Item 1A, Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2008, which was filed with the Securities and Exchange Commission on February 27, 2009. The forward-looking statements in this press release are qualified by these risk factors. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
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