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