Controlling symptoms of menopause

August 5, 2004 -- According to the North American Menopause Society, about 4,000 women in the United States and Canada reach menopause each day. For most of them, the sudden changes in hormone levels that accompany menopause will result in symptoms, such as hot flushes, heart palpitations/irregularities, night sweats, mood swings, irritability, decreased libido, and feminine dryness. These symptoms can make daily life uncomfortable.

Fortunately, treatments are available that relieve symptoms for many women. According to the Food and Drug Administration (FDA), hormone therapy is the most effective treatment available to relieve menopausal symptoms. However, some women don't respond to standard hormone therapy, and continue to be distressed by menopausal symptoms. New treatments are always needed.

Clinical Research Associates® is conducting a research study of an investigational medication to control the symptoms of menopause. The purpose of the research study is to evaluate the safety and effectiveness of the investigational medication in menopausal women whose symptoms have persisted despite receiving standard estrogen hormone therapy.

More About Menopause and Menopausal Symptoms

Menopause is defined as the end of a woman's monthly menstrual periods. This usually occurs between 45 and 55 years of age. In the time leading up to menopause (perimenopause), hormone levels may both rise and drop, disturbing the frequency and intensity of menstrual periods. Periods will become increasingly irregular and then stop. Periods stop when the ovaries produce low levels of hormones or almost none at all. The natural menopausal transition may take from one to ten years.

Menopause may also occur after hysterectomy (surgical removal of the uterus) with oophorectomy (surgical remove of one or both ovaries). This is usually referred to as surgical menopause.

Eighty to eight-five percent of menopausal women will experience symptoms of hormonal adjustment, such as: hot flushes/flashes, heart palpitations/irregularities, night sweats, mood swings, irritability, decreased libido and feminine dryness. Thirty percent of menopausal women will experience severe versions of these symptoms.

The most common and well-known menopausal symptom is hot flushes, also called hot flashes. 75% of menopausal women experience hot flushes. Hot flushes manifest as sudden reddening of the neck and chest, experienced as an explosion of heat, lasting three to four minutes, often followed by profuse sweating. These can occur a few times a month, or several times a day.

Therapies for Controlling Menopausal Symptoms

For many women, symptoms of menopause will fade as the body adjusts to lower hormone levels. For others, however, these symptoms may persist over several months or years, and some treatment or therapy is needed to improve the quality of life. While lifestyle changes including a healthy diet and exercise can help, many women will need medication to control their symptoms.

The most common medical treatment to control menopausal symptoms is called hormone therapy (often called hormone replacement therapy or HRT), which is the most effective treatment available for relieving menopausal symptoms. Some hormone therapies can reduce chances of bones becoming thin and weak later in life (osteoporosis). For some women, hormone therapy may increase their chance of getting blood clots, heart attacks, strokes, breast cancer, and gall bladder disease.

Hormone therapy usually includes the hormone estrogen, and may be supplemented with one of several synthetic progestins (or natural progesterone), especially for women who have not undergone hysterectomy. Other hormone therapy medications pair estrogen with androgens such as testosterone.

In addition to oral medications (pills), hormone therapy can take the form of skin patches, creams, gels, injections, and vaginal rings and tablets. Women may need to try several different types and delivery methods of hormone therapy to determine which works best, and some women will not respond to treatment.

New treatments are continually sought to provide the widest available options for controlling menopausal
symptoms.

Clinical Research Associates® is conducting a research study of an investigational medication to control the symptoms of menopause. The purpose of the research study is to evaluate the safety and effectiveness of the investigational medication in menopausal women whose symptoms have persisted despite receiving standard estrogen hormone therapy. Women interested in volunteering for the study must be between the ages of 40 and 65, menopausal (surgically or naturally), and experiencing persistent symptoms. Participation in the study requires at least five office visits over a period of up to 22 weeks, and includes study-related medical care, including health assessments, lab tests, and study medications. Women interested in volunteering or learning more about the study can contact 1-888-STUDY-97 (1-888-788-3997) or visit www.ClinicalTrials.com/HRT.





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