Hormone therapy has long been the standard treatment for menopause-related conditions, including vaginal atrophy. Hormone therapy is effective in alleviating some symptoms of menopause but, after long-term use, increases the risk of breast and uterine cancer, as shown in the Women's Health Initiative (WHI).

Women and their physicians seeking alternatives to systemic hormone therapies to treat vaginal atrophy typically turn to topical prescription-based hormone treatments. Vaginal delivery of estrogen diminishes, but does not eliminate, the risks of systemic exposure to estrogen. Over-the-counter topical vaginal lubricants are also used, but are messy to apply. Further, such treatments do not change the mucous membrane of the vagina, and thus offer only temporary relief of vaginal atrophy, and can increase vaginal dryness after the lubricant dries.

As a result of the limitations of current therapies, we believe that an oral therapeutic that effectively treats the symptoms of postmenopausal vaginal atrophy without increasing the risk of breast and uterine cancer and which does not induce hot flashes would be an important addition to the therapeutic choices of patients and their physicians.

Post-Women's Health Initiative

In 2004, U.S.hormone therapies sales for menopausal conditions were approximately $1.7 billion, according to IMS Health. This represents a 30% decline from the level of sales prior to publication of the findings of the clinical studies from the WHI. Sales of hormone therapy products containing estrogen alone dropped from $1.5 billion in 2001 to $1.1 billion in 2004 in the U.S., although still accounting for 75% of total 2004 oral hormone therapy prescriptions.