CONTACT: DAVE PEDERSEN
2130 Medical Laboratories
Iowa City IA 52242
(319) 335-8032; fax (319) 335-8034
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
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.