CONTACT: BECKY SOGLIN
Iowa City IA 52242
(319) 335-6660; fax (319) 384-4638
CONTACT: DAVE PEDERSEN
Iowa City IA 52242
(319) 335-8032; fax (319) 384-4638
Release: July 9, 2002
UI Among Centers Ceasing Estrogen Plus Progestin Trial
National Heart, Lung and Blood Institute (NHLBI) announced this morning at
a news conference held in Washington, D.C., that it has stopped early the
estrogen plus progestin portion of the Women's Health Initiative (WHI) after
overall health risks were found to exceed the health benefits. The clinical
trial was designed to assess the major health benefits and risks of estrogen
plus progestin, the most commonly used hormone preparation in the United States
on healthy postmenopausal women with intact uteruses.
The University of Iowa is one of 40 clinical centers in the United States
that enrolled women in this arm of the WHI. Due to the importance of the findings,
the study is being released early by the Journal of the American Medical Association
(JAMA) at its Web site www.jama.com and
will appear in the July 17 issue of the journal. The NHLBI news release is
available online at www.nhlbi.nih.gov/whi/hrtupd/index.htm
All women who have participated in this WHI component are being informed
that the study has stopped and are being asked to return their remaining study
pills. Additional information for participants is posted at www.whi.org/.
A total of 16,608 postmenopausal women ages 50 to 79 were enrolled in the
study between 1993 and 1998. A total of 1,100 women originally were enrolled
at three sites overseen by the UI: Iowa City (398 women originally enrolled),
Des Moines (405 originally enrolled) and Davenport (297 originally enrolled).
Approximately half the participants were randomly assigned to a daily dose
of estrogen plus progestin and half were randomly assigned to a placebo. Even
though the trial has stopped, the UI wants to continue to monitor these participants.
A separate WHI study in which the UI participates involves women who have
had a hysterectomy taking only estrogen. This estrogen-only study will continue,
and women who are participants in this study will be asked continue to take
their study medications. Some women originally enrolled in the estrogen-progestin
study who had a hysterectomy were moved to the estrogen-only trial. These
women, however, will be asked to stop taking their pills.
Women who are participating through the UI in the estrogen-progestin portion
of the WHI or other WHI studies who have questions may call one of these toll-free
or local numbers: Iowa City area (800) 814-9535 Davenport area (800) 344-3515
or (563) 324-3545 Des Moines (800) 347-8164 or (515) 241-8989.
All WHI studies in which the UI participates are based in the Preventive
Intervention Center in the UI College of Public Health. (Information on the
other WHI studies is provided below.)
The following UI investigators were involved in the estrogen-progestin arm
of the WHI. Their roles in the study are indicated first; their UI titles
are listed second.
Robert Wallace, principal investigator for the UI's participation in the
trial M.D., Ph.D., the Irene Ensminger Stecher Cancer Professor and UI professor
of epidemiology and internal medicine.
Susan Johnson, chief gynecologist for the study M.D., UI professor of obstetrics
and gynecology, and associate dean for faculty affairs in the UI Roy J. and
Lucille A. Carver College of Medicine.
James Torner, co-principal investigator Ph.D., UI professor of epidemiology.
Linda Snetselaar, dietary expert Ph.D., UI associate professor of epidemiology.
Bradley Van Voorhis, gynecologist M.D., UI professor of obstetrics and gynecology.
Information about other WHI studies, which will continue and in which the
* The estrogen plus progestin study is one of two studies that make up the
Hormone Replacement Therapy (HRT) clinical trial portion of the WHI. The other
HRT study is the investigation of estrogen alone in women who had a hysterectomy
before joining the WHI program. This study continues unchanged because, as
the NHLBI reports, at this point, the balance of risks and benefits of estrogen
alone still is uncertain. The estrogen-only study involves a total of 10,739
women nationwide. The UI originally enrolled 562 women in this trial.
The UI participates in two other clinical studies that are part of the WHI.
Among women who are part of the estrogen-progestin trial being stopped, many
have been participating in, and are eligible to continue participating in,
one of these two clinical studies: the dietary modification arm or the calcium
plus vitamin D arm, both of which are described below.
* Dietary Modification Study - This WHI trial studies the effects of low-fat
eating patterns on breast and colorectal cancer, heart disease and other disease
outcomes. More than 48,000 women ages 50 to 79 are participating nationwide
in this component. The UI originally enrolled 1,003 women in this dietary
* Calcium plus Vitamin D Supplementation Study - Women enrolled in this trial
are either taking these supplements or a placebo. This trial is designed to
study the effects of calcium plus vitamin D on hip and other fractures, colorectal
cancer and other disease outcomes. Women in this trial are either enrolled
in the dietary trial or one of the hormone arms (no one is enrolled only in
the calcium plus vitamin D trial). Approximately 45,000 postmenopausal women
ages 50 to 79 are enrolled nationwide in the study. The UI originally enrolled
1,535 women in this supplementation study.
Altogether, the two HRT studies, the dietary modification study and the calcium
plus vitamin D study originally enrolled through the UI approximately 2,400
women, with some women participating in two or more studies.
The UI also participates in an observational trial that is part of the WHI:
*This observational trial tracks the health of more than 93,000 women between
ages of 50 and 79. The study goals include learning more about health risk
factors, including reliable estimates of the extent to which known risk factors
predict heart disease, cancers and fractures. The UI originally enrolled 3,118
women in the WHI observational study.
The WHI also includes a Community Prevention Study, a five-year cooperative
venture with the Centers for Disease Control and Prevention that is a study
of strategies to enhance adoption of healthful behaviors through a multi-disciplinary
approach. However, the UI does not participate in this study.
A backgrounder on the WHI is available online at www.nhlbi.nih.gov/whi/factsht.htm