Important Notice About Your Study
Dear Ms. [Estrogen Plus Progestin trial
I am writing to tell you important news about the
WHI Hormone Program you are in. You may recall that this is the study of
estrogen plus progestin for women who had not had a hysterectomy before joining
the WHI. At its most recent meeting, the WHI Data and Safety Monitoring Board
(DSMB) recommended that women in the estrogen plus progestin study stop their
study pills. In their judgment, it has become clear that the health risks of
taking estrogen plus progestin now exceed the benefits.The DSMB made this
recommendation because of the following risks:
On the other hand, there were benefits of taking
estrogen plus progestin:
- The number of women who developed breast cancer
was higher in women taking estrogen plus progestin pills than in women taking
- The numbers of women who developed heart
attacks, strokes, and blood clots were higher in women taking estrogen plus
What are we asking you to do? Please
follow these instructions:
- The numbers of women who had fractures or
colorectal cancer were lower in women taking estrogen plus progestin.
- Stop taking your study pills. Most of you
will probably have no effects from stopping your pills. Some of you may have
some menopausal symptoms like hot flashes, or you may have mild spotting or
bleeding. These symptoms should decrease over time. Please contact your clinic
if you have concerns.
- Complete the enclosed "Medical History Update"
and return it to your clinic as soon as possible. This update will help us
to study all health events that have occurred.
- Review and sign the enclosed "Signature Sheet"
and return it with your "Medical History Update". We want to be sure that
you have received this information.
- Do not throw away any left-over hormone study
pills or bottles. Your clinic staff will let you know how to return them at
your next contact.
- Continue your regularly scheduled clinic
contacts. For your safety, we want you to get yearly mammograms and your WHI
clinic exams. We also have much more to learn from the Hormone Program even
after you stop taking study pills.
- Continue to participate in any other WHI
programs you joined. For example, if you are in the Calcium and Vitamin D
Program, please continue to take those study pills as you have in the past.
There are still many important questions to answer about women's health.
I have asked the Clinical Coordinating Center to
send you this letter. More information is available in the attached "WHI HRT
Update" and on the World Wide Web at:
http://www.whi.org. Please share this information
with your health care provider. Your local WHI clinic will be contacting you so
you can hear more about these results and have your questions answered. You can
also contact the [clinic name] clinic staff at [clinic phone
number] if you have urgent questions.
These results are enormously important and will
inform millions of women and their doctors worldwide about the risks and
benefits of estrogen plus progestin. The findings from this study could not
have been predicted when we began in 1993. You are a vital part of this
historic study, which is expected to influence medical care for current and
Thank you for your dedication, both past and
future, to the WHI Hormone Program.
Claude Lenfant, MD
National Heart, Lung, and Blood
cc: Dr. [PI first and last name], Principal
Investigator, [clinic name]