Executive SummaryThe number one complaint of women undergoing menopause is a vasomotor instability that presents as hot flashes and sweats. A hot flash is a sudden onset of intense body heat with profuse perspiration and reddening of the skin over the head, neck and chest. Flashes last from a few seconds to several minutes and are more frequent and severe at night, when they awaken women from sleep. The frequency varies greatly.After menopause, the mortality rate from CHD increases greatly. In fact, it is the leading cause of death in older women. As experience is gained in tracking women on hormone replacement therapy, the positive effects of treating women with estrogen are becoming apparent. In 1992 Grady et al. published a study in the Annals of Internal Medicine that analyzed 32 epidemiologic studies. All but one showed that estrogen use lowers the risk of CHD by 35%.A study published in January 1996 in the Journal of Obstetrics and Gynecology provided additional evidence of benefit to postmenopausal women of taking estrogen. In women over the age of 80, the rate of death from all causes was 46% less in the group receiving hormone replacement therapy. This group had a 60% reduction in coronary heart disease and 73% reduction in mortality related to stroke.In addition to women undergoing natural menopause, every year a large number of women undergo the removal of their uterus, or hysterectomy. This is the second most performed surgery in the US; only cesarean sections are performed more often. There are many clinical reasons for this procedure. It is often done as a life-saving procedure in order to remove cancers, to stop hemorrhaging, or to treat infections.Women who have undergone a surgical menopause caused by the removal of their ovaries are also considered to be candidates for therapy. In fact, because surgical menopause is more abrupt than natural menopause, women who undergo hysterectomies have more symptoms and a greater need for therapy. A majority of physicians believe that, because these women do not have an endometrium, it is acceptable to give unopposed estrogen.Disturbingly, in the June 15, 1995 issue of the New England Journal of Medicine, results were published from the Nurses' Health Study that was initiated in 1976 and extended to qualify the relationship between the use of hormones and the risk of breast cancer in postmenopausal women. The women in the study group were asked to fill out questionnaires every two years to update information on their menopausal status, use of HRT, and any diagnosis of breast cancer. The risk of breast cancer was significantly increased among women who were currently using estrogen alone or estrogen plus progestin, as compared with post-menopausal women who had never used hormones.Intravaginal rings are under development by several companies. The advantage of these delivery systems is the ability to provide continuous delivery of estrogen and progestin for up to 3 months. This is especially appealing in treatment of women who are unable to see a physician as often, or who may have difficulty remembering to take a daily medication, as in the case of certain women in a nursing home environment, or those suffering from Alzheimer's or other dementia.Menopausal therapy is one of the truly exciting growth markets of the future. The population in the age segment that is most affected is projected to increase by 40% between 1994 and 2010. The percent of women seeking therapy and the physicians who believe that therapy is necessary is also expected to increase as evidence of the benefits mounts. The number of women under 50 with ovariectomies will also contribute to this growing market.