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Release: March 1, 2000

Women are invited to participate in UI study involving low-dose estrogen

IOWA CITY, Iowa -- Researchers at the University of Iowa College of Public Health are testing an ultra-low dose of estrogen in a skin patch to learn whether it is safe and effective for preventing osteoporosis.

Estradiol skin patches are currently available in doses of 0.05 mg/day. The UI study will test whether a dose one quarter that size (0.0125 mg/day) is effective and may also minimize some of the risks and side effects associated with hormone replacement therapy.

"The study of lower dose estrogen is particularly important because it examines whether a woman can receive the positive effects of estrogen without some of the possible side effects," said Robert Wallace, M.D., UI professor of epidemiology and principal investigator for the study. "This ultra-low dose of estrogen that we are testing in this study does not contain progestin, which is added to the standard hormone therapy combination to help prevent the increase in risk for endometrial cancer, which is cancer of the lining of the uterus."

According to Wallace, using ultra-low dose estrogen without the added progestin, women would not experience the side effects that are common with the combination of estrogen and progestin in hormone replacement therapy.

Volunteers for this study must:

-- be between the ages of 60-80;

-- be five years postmenopausal (no menstrual period for at least five years);

-- have their uterus (not have had a hysterectomy);

-- not have osteoporosis, heart disease or hypertension;

-- not be currently taking hormone replacement therapy.

The study will last two years and will consist of eight visits to the clinic in Iowa City. Study tests include bone density measurements, gynecological examinations such as Pap and pelvic exams, and mammograms. Study participants may receive either the ultra-low dose of estradiol in the skin patch or a placebo (inactive) skin patch. In addition, all study participants will receive calcium supplements and multi-vitamins.

The study is being conducted by the Preventive Intervention Center in the UI department of epidemiology, which since 1992 has been doing clinical trials to learn more about preventing diseases and conditions that affect women after menopause. Approximately 135 women will be enrolled in this nationwide study at the clinic in Iowa City. Other study clinics are located in Minnesota and California.

For more information, call the Preventive Intervention Center at (319) 335-6628, or toll-free (800) 348-4692.

University of Iowa Health Care describes the partnership between the UI College of Medicine and the UI Hospitals and Clinics and the patient care, medical education and research programs and services they provide.