At menopause, women experience a dramatic drop in the production of the hormones estrogen and progesterone. Prescription hormone therapy contains estrogens, and women sometimes take prescription hormone therapy to treat some of the physical and psychological effects of these hormonal changes, including hot flashes, sleep disturbances, and mood alteration. Novasoy®400 is a soy-based dietary supplement that contains plant estrogens and is therefore called a phytoestrogen.
In many ways, a phytoestrogen acts similar to estrogen in the body. Many women are already using Novasoy®400 for the relief of menopausal symptoms like hot flashes. This product is commonly available through health food stores and can be obtained without a prescription.
Studies in women’s health do not provide a clear indication of whether soy improves hot flashes or not. We still do not know everything about the effects of phytoestrogens, such as soy, on hot flashes, mood, memory complaints, and anxiety and other menopausal symptoms in women.
The goal of RISE is to examine the effects of soy (NovaSoy®400) and estrogen on these menopausal symptoms in perimenopausal women. RISE is sponsored by the National Institute of Mental Health (NIMH).
Frequently Asked Questions:
Perimenopause is the time when your body begins its transition into menopause. It is usually marked by changes in your cycle length where it may become longer or shorter. Members of the research team will work with you to determine if you are perimenopausal. This is determined by reports of your cycle lengths and hormone levels. Your hormone levels will be determined by a blood draw.
Participants will be randomized to receive one of three treatments: estrogen, Novasoy ®400, or placebo. Thirty-three percent of the participants will receive estrogen, 33% will receive Novasoy ®400 and 33% will receive placebo. This is a blinded study meaning neither you nor the researchers will know what treatment you are receiving. All of the pills have been designed to look the same in order to maintain the blind.
RISE is conducted by the Women’s Mental Health Program and the Center for Cognitive Medicine at the University of Illinois at Chicago, located in the Neuropsychiatric Institute at 912 South Wood Street. It is conveniently located less than two blocks from the CTA Polk Pink line el stop. The #7 and #157 CTA buses also stop at the CTA Polk station. The Illinois Medical District Blue line stop is also nearby. From the blue line, the Neuropsychiatric Institute is approximately a 15 minute walk. More information about the Center for Cognitive Medicine can be found at http://ccm.psych.uic.edu/.
During the course of the study, there will be seven visits to the University of Illinois at Chicago. Certain visits will check your physical status while others will be comprised of different cognitive tests and questionnaires. The length of the visits will vary as well as the times of the day in which they occur.
At the completion of the study, you will receive $200 in the form of a check. If you do not complete the study, you will receive a prorated amount. You will be reimbursed for the parking expenses for each visit.