Feb. 21, 2001 Researchers at the National Institute of Child Health and Human Development (NICHD) are recruiting women who have premature ovarian failure--formerly known as premature menopause--to determine if restoring testosterone will help prevent osteoporosis.
According to Lawrence M. Nelson, M.D., head of NICHD's Unit on Gynecologic Endocrinology, the women will receive testosterone in addition to the combination of replacement hormones (estrogen and progestin) prescribed for women with premature ovarian failure. The testosterone will be delivered through a patch worn on the skin.
"Many women who experience premature ovarian failure don't realize how important it is to replace the hormones that the ovary no longer provides," Dr. Nelson said. "We're testing a new method to improve replacing these ovarian hormones."
Normally, the ovaries produce both estrogen and testosterone, Dr Nelson explained. Some young women become deficient in these hormones because their ovaries, for unknown reasons, stop working prematurely. When this happens before age 40, the condition is known as premature ovarian failure. Testosterone is believed to be important for a woman's health but is not typically replaced in women who have low levels of this hormone. Many experts believe that testosterone plays a key role in maintaining a woman's sexual desire and other aspects of sexual function, and may contribute to her bone and muscle mass, strength, energy level, and a positive sense of well being. Testosterone may also benefit some aspects of memory.
"We know that women with premature ovarian failure as a group have decreased testosterone levels," says Sophia Kalantaridou, M.D., Ph.D., the study's lead investigator. "This study is primarily designed to determine if returning their testosterone levels to normal through the use of this testosterone skin patch will help them better maintain bone density." The research is being conducted by the Gynecologic Endocrinology Unit at the National Institutes of Health in Bethesda, Maryland under a Collaborative Research and Development Agreement between the National Institutes of Health and Procter and Gamble Pharmaceuticals.
Women who volunteer for the study will have the opportunity to come to NIH to be evaluated by a team of physician experts in premature ovarian failure. The evaluation will be provided at no charge, and, in most cases, patients will be reimbursed for their travel expenses.
"By participating, study volunteers will help answer questions about how best to treat patients with premature ovarian failure," Dr. Nelson said. "We also take patient education seriously, and will do our utmost to help volunteers develop a thorough understanding of their condition."
The researchers plan to recruit three groups of 55 women each. The first group of women with premature ovarian failure will wear an experimental skin patch that delivers the amount of testosterone normally produced by the ovary in healthy young women. These women will be compared to a second group of women with premature ovarian failure who will wear a placebo patch (a patch that delivers no hormone). Women in both groups will also wear a patch that delivers estrogen and take tablets containing the hormone progestin. These two groups of women will be compared with a third group of women who have normal ovarian function. All the women in the study will receive periodic scans to measure bone density as well as tests of cognition, mood, well being, sexual function, dry eye, and body composition.
Patient Contact Information:
For information on how to participate in the study, potential volunteers with premature ovarian failure--as well as women with normally functioning ovaries--between the ages of 18 and 42 may contact Vien Vanderhoof by calling toll free at 877-206-0911.
The NICHD is part of the National Institutes of Health, the biomedical research arm of the Federal government. The Institute sponsors research on development before and after birth; maternal, child, and family health; reproductive biology and population issues; and medical rehabilitation. NICHD publications, as well as information about the Institute, are available from the NICHD website, http://www.nichd.nih.gov, or from the NICHD Clearinghouse, 1-800-370-2943; E-mail NICHDClearinghouse@mail.nih.gov.
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