Frequently Asked Questions about the WHI Estrogen plus Progestin Trial
Issues Specific to Women in the Estrogen plus Progestin Study
These questions and answers supplement the 2002 WHI HRT Update sent to all WHI participants in July 2002.
- Will I be told whether I was taking active or inactive (placebo) pills?
- Why should I continue to participate after I have stopped my hormone study pills?
- Why do I need to sign the Signature Statement?
- Why do I need to fill out a Medical History Update at this time?
- Why do I need to return my unused study pills?
- I had a hysterectomy after I joined the estrogen plus progestin study. Do I need to stop my study pills?
- Is it safe to stop my estrogen plus progestin study pills all at once or should I be slowly tapering the dosage?
- Will my hot flashes come back if I stop my study pills?
1. Will I be told whether I was taking active or inactive (placebo) pills?
Answer: Yes, all participants in the study of estrogen plus progestin will be told whether they were taking active study pills or placebo pills. Your local WHI clinic will contact you within the next month about getting this information. If you would like the information before you hear from the clinic, you may contact them sooner.
2. Why should I continue to participate after I have stopped my hormone study pills?
Answer: We now have a new, equally important, question to answer--how long do the risks and benefits of taking estrogen plus progestin persist? This question can only be answered if you continue to participate, whether you were taking placebo pills or active estrogen plus progestin.
We would like you to continue having your yearly mammograms and other health exams and continue filling out the health updates so that we can monitor your health on a regular basis. With this health information, we will also know about any changes that occur after you have stopped taking your WHI hormone study pills.
The Data and Safety Monitoring Board will continue to monitor participants’ health data every 6 months.
Note: If you are also in the Calcium and Vitamin D Program, please continue taking those study pills. This new information does not change anything about your participation in that study. Your continued participation will help us to understand the role of calcium and vitamin D supplements in women’s health, even after you stop taking your estrogen plus progestin study pills.
3. Why do I need to sign the Signature Statement?
Answer: We want to be sure that each woman in the estrogen plus progestin study receives the new information and understands that she has been asked to stop her WHI study pills. If we do not receive your signature sheet, your local WHI clinic will contact you to be sure that you get this important information.
4. Why do I need to fill out a Medical History Update at this time?
Answer: In order to have full health information about participants while they were taking study pills, we need to have you complete a Medical History Update form before you stop taking your study pills, or as soon thereafter as possible.
Even if you previously stopped your study pills, filling out the form is still important. Your health information is analyzed along with the data from all the other women in the estrogen plus progestin study.
5. Why do I need to return my unused study pills?
Answer: As always, we need to have a full and accurate accounting of participants’ study pills to ensure there is no improper or mistaken use.
6. I had a hysterectomy after I joined the estrogen plus progestin study. Do I need to stop my study pills?
Answer: Yes. If you had a hysterectomy during the study, you were switched to estrogen only study pills. However, because you were originally taking estrogen plus progestin study pills, whether active or placebo, you should now stop your hormone study pills. The intervention (pill-taking) phase of the study you are in has ended. We are now asking you to continue in the follow-up phase of the estrogen plus progestin study. We do not know how the risks (or benefits) change for women who were taking estrogen plus progestin pills but then switched to estrogen alone study pills.
You should talk with your health care provider to determine whether you should take prescription estrogen alone based on your individual health risk profile.
7. Is it safe to stop my estrogen plus progestin study pills all at once or should I be slowly tapering the dosage?
Answer: There is no evidence that stopping your estrogen plus progestin study pills all at once is harmful. Some physicians recommend women slowly cut down their hormone dosage before stopping entirely. This advice is based on the fact that a woman may have rapid onset of menopausal symptoms when natural estrogen levels drop after a hysterectomy. There is not sufficient research to tell us if women who stop hormone medications also have this rapid onset of menopausal symptoms. The health information you continue to provide for the WHI will help us learn more about what happens when women stop their study pills.
8. Will my hot flashes come back if I stop my study pills?
Answer: Women who stop active estrogen plus progestin study pills may have hot flashes or other menopausal symptoms for a time, particularly if they had these symptoms before joining WHI. Women who were taking placebo study pills will probably not notice any changes after they stop study pills. If you do have hot flashes after you stop your study pills, we recommend that you contact your health care provider. Some women who have hot flashes find that cutting out caffeine and alcohol and dressing in layers can be helpful.