Women’s Health Initiative (WHI)

The Women’s Health Initiative (WHI) study evaluated, among other things, a specific combination of hormone therapy (conjugated estrogens and medroxyprogesterone acetate, under the brand name Prempro). In 2002, the estrogen and progestin therapy arm of the WHI study was stopped early because the combination of estrogen and progestin used increased the risk of breast cancer, heart attacks, stroke and blood clots.

Patients in the WHI study were postmenopausal and took the pills over long periods. The FDA and the North American Menopause Society (NAMS) now recommend smaller doses over a shorter time for temporary symptom relief.

For more information on study results, visit http://www.whi.org/findings
Estrogens and progestins should not be used for the prevention of cardiovascular disease or dementia.

The Women’s Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5 years of treatment with oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) relative to placebo.

The Women’s Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with oral conjugated estrogens plus MPA relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.

Other doses of oral conjugated estrogens with MPA, and other combinations and dosage forms of estrogens and progestins were not studied in the WHI clinical trials and, in the absence of comparable data, these risks should be assumed to be similar. Because of these risks, estrogens with progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.

Estrogens and estrogens/progestins combined should not be used in women with undiagnosed abnormal genital bleeding; known, suspected, or history of breast cancer; known or suspected estrogen-dependent neoplasia; active deep vein thrombosis, pulmonary embolism, or history of these conditions; active or recent arterial thromboembolic disease; liver dysfunction or disease; or known or suspected pregnancy.

In clinical trials with CombiPatch, the most common side effects were breast pain, dysmenorrhea, and headache.

CombiPatch is indicated for women with an intact uterus for the treatment of moderate to severe vasomotor symptoms associated with menopause, and moderate to severe symptoms of vulvar and vaginal atrophy associated with menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.



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