 |
|
|
 |
NIH asks participants in women’s health initiative estrogen-alone study to stop study pills, begin follow-up phase
The National Institutes of Health (NIH) has instructed participants in the estrogen-alone study of the Women’s Health Initiative (WHI), a large multi-center trial, to stop taking their study pills and to begin the follow-up phase of the study.
more
|
|
Information for patients: Questions and answers about the estrogen-alone study
The NIH carefully reviewed the latest data and concluded that, with nearly 7 years of follow-up completed, estrogen-alone hormone therapy does not appear to affect (either decrease or increase) the risk of heart disease--the main question of the trial. more
|
|
Information for patients: Questions and answers about estrogen-plus-progestin hormone therapy
The long-term studies in the WHI were initiated because over the years a number of research studies presented a complicated picture of the risks and benefits of hormone therapy, and its continued use for prevention of cardiovascular diseases was controversial. This situation led the NIH to conduct a large clinical trial of the risks and benefits of hormone therapy.
more
|
|
|
|
NHLBI Advisory for Physicians on the WHI trial of Conjugated Equine Estrogens vs Placebo
On March 1, 2004, the National Institutes of Health (NIH) informed study participants that they should stop study medications in the trial of conjugated equine estrogens (Premarin™, Estrogen-alone) versus placebo in the Women's Health Initiative (WHI). Women will continue to be followed for several more years, including ascertainment of outcomes and mammogram reports.
more
|
|
FDA plans to evaluate results of women's health initiative study for estrogen-alone therapy
The Food and Drug Administration said today that it plans to assess the latest
results for the estrogen-alone trial of the Women's Health Initiative
(WHI) study to determine whether the data supports additional labeling changes
for postmenopausal hormone therapy. more
|
|
Prescribing information: Premarin (conjugated estrogens tablets)
Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic
measures, including endometrial sampling when indicated, should be undertaken to rule out
malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding.
There is no evidence that the use of “natural” estrogens results in a different endometrial risk profile than synthetic estrogens of equivalent estrogen dose.
more
|
|
The estrogen and progestin dilemma: New advice, labeling guidelines
The Food and Drug Administration is repeating important safety advice to postmenopausal women and their health-care providers concerning drug products that contain estrogen. The updated advice, which includes product label revisions, reflects the agency's review of data from the Women's Health Initiative (WHI) study, sponsored by the National Institutes of Health. more
|
|
|
