PHILADELPHIA –Women troubled by hot flashes and night sweats during the years around menopause want safe, effective treatment options. The School of Medicine is part of a new National Institutes of Health (NIH) initiative to conduct clinical trials of promising treatments for the most common symptoms of the menopausal transition.
The initiative-Menopause Strategies: Finding Lasting Answers for Symptoms and Health (MsFLASH)-is led by the National Institute on Aging (NIA) in collaboration with the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the National Center for Complementary and Alternative Medicine (NCCAM) and the Office of Research on Women's Health (ORWH), all parts of the NIH. The network centers will collectively receive approximately $4.4 million each year of the initiative, which is projected to run for five years. The Penn portion of the five-center study will be led by Ellen W. Freeman, PhD, Research Professor and Co-Director of the Human Behavior and Reproduction Unit in Obstetrics and Gynecology at Penn.
“Studies such as the Women's Health Initiative, which raised concerns about the safety of using menopausal hormone therapy, underscore the urgent need for treatments that have been proven safe and effective for alleviating menopausal symptoms,” said NIA Director Richard J. Hodes, M.D. "MsFLASH will speed the evaluation of treatments deemed promising by an independent panel at the recent NIH State-of-the-Science Conference on the Management of Menopause-Related Symptoms."
Different treatments will be studied for their effectiveness against hot flashes and night sweats in diverse groups of women in trials with either placebo or usual-care control groups. The usual care group does not use a placebo pill. Investigators will also look at possible effects on other symptoms at middle age, including sleep disturbance, mood changes, vaginal dryness, and sexual function. Possible treatments to be studied during the five-year project period include:
- Antidepressants such as paroxetine (Paxil) or escitalopram (Lexapro)
- Paced respiration (slow deep breathing also known as relaxation breathing)
- Low-dose estradiol patch and low-dose estradiol gel
- Exercise programs, both moderate and vigorous
The target date to start trials is June 2009. The Penn trial aims to recruit approximately 190 women from diverse ethic backgrounds.
“Estradiol is the only FDA-approved treatment for hot flashes at this time," states Freeman. "Researchers have studied other treatments but the studies have been small, often uncontrolled, and results are conflicting. Increased information about treatment effectiveness in larger, placebo-controlled trials with diverse participants will lead to better therapeutic strategies for women who experience distressing and disruptive menopausal symptoms."
PENN Medicine is a $3.6 billion enterprise dedicated to the related missions of medical education, biomedical research, and excellence in patient care. PENN Medicine consists of the University of Pennsylvania School of Medicine (founded in 1765 as the nation's first medical school) and the University of Pennsylvania Health System.
Penn's School of Medicine is currently ranked #4 in the nation in U.S.News & World Report's survey of top research-oriented medical schools; and, according to most recent data from the National Institutes of Health, received over $379 million in NIH research funds in the 2006 fiscal year. Supporting 1,700 fulltime faculty and 700 students, the School of Medicine is recognized worldwide for its superior education and training of the next generation of physician-scientists and leaders of academic medicine.
The University of Pennsylvania Health System (UPHS) includes its flagship hospital, the Hospital of the University of Pennsylvania, rated one of the nation's top ten "Honor Roll" hospitals by U.S.News & World Report; Pennsylvania Hospital, the nation's first hospital; and Penn Presbyterian Medical Center. In addition UPHS includes a primary-care provider network; a faculty practice plan; home care, hospice, and nursing home; three multispecialty satellite facilities; as well as the Penn Medicine Rittenhouse campus, which offers comprehensive inpatient rehabilitation facilities and outpatient services in multiple specialties.