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Estradiol and Progesterone Capsule
  • Professionals
  • FDA PI

Estradiol and Progesterone Capsule

Dosage form: capsule
Drug class:Sex hormone combinations

Medically reviewed by Drugs.com. Last updated on Mar 1, 2022.

WARNING: CARDIOVASCULAR DISORDERS, PROBABLE DEMENTIA, BREAST CANCER, and ENDOMETRIAL CANCER

Estrogen Plus Progestin Therapy

Cardiovascular Disorders and Probable Dementia

The Women’s Health Initiative (WHI) estrogen plus progestin substudy reported increased risks of pulmonary embolism (PE), deep vein thrombosis (DVT), stroke, and myocardial infarction (MI) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg] combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo [see Warnings and Precautions (5.1), and Clinical Studies (14.4)].

The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study of WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age and older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women [see Warnings and Precautions (5.3), Use in Specific Populations (8.5), and Clinical Studies (14.5)].

Do not use estrogen plus progestogen therapy for the prevention of cardiovascular disease or dementia [see

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