A total of 462 postmenopausal women with intact uteri and baseline BMD values for lumbar spine within 2 standard deviations of the mean in healthy young women (T-score > - 2) were enrolled. Adding a progestin to estrogen therapy in postmenopausal women has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer.The WHI estrogen plus progestin substudy reported a statistically non-significant increased risk of ovarian cancer. Talk with your doctor about this risk.Mimvey can slow breast milk production. The increase in lumbar spine BMD in the US and European clinical trials for Mimvey 1 mg/0.5 mg and estradiol 0.5 mg is displayed in Figure 6.The WHI enrolled approximately 27,000 predominantly healthy postmenopausal women in two substudies to assess the risks and benefits of daily oral CE (0.625 mg)-alone or in combination with MPA (2.5 mg) compared to placebo in the prevention of certain chronic diseases. Oral route (Tablet) Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia.An increased risk of DVT, pulmonary embolism, stroke, myocardial infarction, and invasive breast cancer have been reported. The most common classification of probable dementia in the treatment group and the placebo group was AD. WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER, ENDOMETRIAL CANCER AND PROBABLE DEMENTIAEstrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia The Women’s Health Initiative (WHI) estrogen plus progestin substudy reported increased risks of deep vein thrombosis (DVT), pulmonary embolism (PE), stroke and myocardial infarction (MI) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral conjugated estrogen (CE) [0.625 mg] combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. Mimvey 1 mg/0.5 mg and estradiol 0.5 mg also increased BMD at the femoral neck and femoral trochanter compared to placebo. ** Significantly (p < 0.007) different from placebo***Significantly (p < 0.002) different from placeboThe overall difference in mean percentage change in BMD at the lumbar spine in the US trial (1000 mg/day calcium) between Mimvey 1 mg/0.5 mg and placebo was 5.9 percent and between estradiol 0.5 mg and placebo was 4.4 percent. Version: 6.03.The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Administration of Mimvey 1 mg/0.5 mg with food increases norethindrone AUCAUC = area under the curve, 0 − last quantifiable sampleFollowing continuous dosing with once-daily administration of Mimvey 1 mg/0.5 mg, serum concentrations of estradiol, estrone, and norethindrone reached steady-state within two weeks with an accumulation of 33 to 47% above concentrations following single dose administration. You can ask your pharmacist or healthcare provider for information about Mimvey and Mimvey Lo that is written for health professionals.The 1 mg/0.5 mg tablet also contains hypromellose, polyethylene glycol, polysorbate 80, and titanium dioxide.This Patient Information has been approved by the U.S. Food and Drug Administration.Each white tablet contains 1 mg estradiol, USP and 0.5 mgThe easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Estradiol is converted reversibly to estrone, and both can be converted to estriol, which is a major urinary metabolite. There may be new information. However, bleeding tended to decrease over time, and after 12 months of treatment with Mimvey 1 mg/0.5 mg, about 86 percent of women were amenorrheic (see Figure 4).Note: The percentage of patients who were amenorrheic in a given cycle and through cycle 13 is shown.If data were missing, the bleeding value from the last reported day was carried forward (LOCF).In the clinical trial with Mimvey Lo 0.5 mg/0.1 mg, 88% of women were amenorrheic after 6 months of treatment (See Figure 5).The results of two randomized, multicenter, calcium-supplemented (500 to 1000 mg per day), placebo-controlled, 2 year clinical trials have shown that Mimvey 1 mg/0.5 mg and estradiol 0.5 mg are effective in preventing bone loss in postmenopausal women. The WHI estrogen-alone substudy, stratified by age, showed in women 50 to 59 years of age a non-significant trend toward reduced risk for CHD The WHIMS estrogen plus progestin ancillary study of WHI enrolled 4,532 predominantly healthy postmenopausal women 65 years of age and older (47 percent were 65 to 69 years of age, 35 percent were 70 to 74 years of age, 18 percent were 75 years of age and older) to evaluate the effects of daily CE (0.625 mg) plus MPA (2.5 mg) on the incidence of probable dementia (primary outcome) compared to placebo.After an average follow-up of 4 years, the relative risk of probable dementia for CE plus MPA versus placebo was 2.05 (95 percent CI, 1.21 to 3.48).