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Release: April 27, 1999

Women invited to join UI hormone replacement study

IOWA CITY, Iowa -- The University of Iowa College of Medicine is seeking volunteers for a seven-month study of a new, investigational combination of hormones.

The combination of norethindrone acetate and ethinyl estadiol is not actually new. It is currently available for birth control but UI researchers are testing lower doses as a postmenopausal hormone replacement therapy.

"Of particular interest is how this combination affects lipid levels," said Helmut Schrott, M.D., UI professor of preventive medicine and environmental health and the study's principal investigator. "Elevated lipid levels are associated with heart disease.

The study also will look at the effects of the combination of hormones on menopausal symptoms, such as hot flashes, and on bone loss.

"More research is needed" is what many postmenopausal women hear when they ask about the benefits and risks of hormone replacement therapy. There is some indication that hormones may help prevent heart disease and osteoporosis but more study is needed to say this with certainty, according to Susan Johnson, M.D., UI professor of obstetrics and gynecology and associate dean for faculty affairs at the medical college.

"In addition, we need to have as many options as possible for women who want to take hormones. This study will look at the risks and benefits of a combination of hormones not commonly used yet by postmenopausal women. By having lots of combinations to choose from, women are more likely to find a plan that works for them," Johnson said.

Women age 40 and older who have undergone menopause in the past eight years may qualify for the study. To be eligible, women must have not had a menstrual period for at least one year, must not be currently taking hormone replacement therapy and must have not have undergone a hysterectomy (removal of the uterus).

Volunteers will receive a physical exam with a PAP test, a transvaginal ultrasound and a mammogram. There will be blood tests at each of the five visits to the research clinic in Iowa City. Study participants will be randomly assigned to receive the new combination of hormones, the drug PremPro (estrogen and progesterone) or a placebo.

For more information, call the UI Preventive Intervention Center at (319) 353-4333 or toll free at 1-800-348-4692.