Side Effects, Interactions, Warning, Dosage & Uses. CLINICAL PHARMACOLOGYEndogenousestrogens are largely responsible for the. Although circulating estrogens exist in a dynamic equilibrium. The primary source of estrogen in normally. After. menopause, most endogenous estrogen is produced by conversion of. Thus, estrone and the sulfate conjugated form, estrone sulfate, are. Estrogens act through binding to nuclear receptors in estrogen- responsive. To date, two estrogen receptors have been identified. These vary in. proportion from tissue to tissue.
Learn about Alora (Estradiol Transdermal System) may treat, uses, dosage, side effects, drug interactions, warnings, patient labeling, reviews, and related medications. Find patient medical information for Estradiol Oral on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings. White active film-coated tablets: Each film-coated tablet contains 2.5 mg nomegestrol acetate and 1.5 mg estradiol (as hemihydrate). Yellow placebo film-coated. An estradiol test is a blood test that measures the amount of estradiol in your blood. It’s also called an E2 test. Estradiol is a form of the hormone estrogen, and. If you’re getting your hormones from a physician I would ask them for another option. Ethinyl estradiol is significantly riskier (in terms of. Circulating estrogens modulate the pituitary. LH) and follicle stimulating. FSH) through a negative feedback mechanism. Estrogens act to reduce. Pharmacokinetics. The skin metabolizes estradiol only to a small extent. In. contrast, orally administered estradiol is rapidly metabolized by the liver to estrone. Therefore, transdermal administration produces therapeutic plasma. Absorption. Estradiol is transported across intact skin and into the. Alora presents. sufficient concentration of estradiol to the surface of the skin to maintain. Direct measurement of total absorbed dose of estradiol. Alora was 0. 0. 03 . The nominal mean in vivo daily. Mean steady- state estradiol serum. Figure 1. Figure 1: Mean steady- state estradiol serum. Alora 0. 1 mg/day, Alora 0. Alora 0. 0. 5 mg/day in 2. In a single dose randomized crossover study conducted to. Alora application, 3. Alora 0. 0. 5 mg/day for 4- day periods on the lower abdomen, upper. The estradiol serum concentration. Figure 2. Figure 2: Mean estradiol serum concentrations. Alora 0. 0. 5 mg/day applied by 3. Table 1 provides a summary of the estradiol. Alora. Table 1 : Mean (SD) Pharmacokinetic Profile of Alora. Over an 8. 4- hour Dosing Interval. MedsChat.com is a popular drug forum. Featuring frequently updated message boards and an extensive index for medicine, health conditions, and drug information. Alora (mg/day)Application Site. NDosing. Cmax (pg/ml)Cmin (pg/ml)Cavg (pg/ml)CL (L/hr)0. Abdomen. 20. Multiple. Abdomen. 20. Multiple. Abdomen. 42. Multiple. Abdomen. 31. Single. Buttock. 31. Single. Hip*3. 1Single. 69 (3. Cmax and Cavg statistically different from abdomen. Steady- state estradiol serum concentrations were measured. Studies 1 and 2), and one trial in the prevention of. Study 3). Table 2 provides a. Table 2: Mean (SD) steady- state estradiol serum. Studies 1 and 2) and 2. Study 3) duration. Alora (mg/day)Study 1. Study 2. Study 3. In a 2- year, randomized, double- blind. These values were linearly related and dose. Distribution. No specific investigation of the tissue distribution of. Alora in humans has been conducted. The distribution. Estrogens. are widely distributed in the body and are generally found in higher. Estrogens circulate in the. SHBG) and albumin. Metabolism. Exogenous estrogens are metabolized in the same manner as. Circulating estrogens exist in a dynamic equilibrium of. These transformations take place mainly in the. Estradiol is converted reversibly to estrone, and both can be converted. Estrogens also undergo. In postmenopausal women a significant portion. Excretion. Estradiol, estrone and estriol are excreted in the urine. The apparent mean (SD) serum. Alora. is 1. 7. 5 . There are no long term. No pharmacokinetic. Drug Interactions. In vitro and in vivo studies have shown that estrogens. P4. 50 3. A4 (CYP3. A4). Therefore, inducers. CYP3. A4 may affect estrogen drug metabolism. Inducers of CYP3. A4. such as St. John's Wort preparations (Hypericum perforatum), phenobarbital, phenytoin. Inhibitors of CYP3. A4 such as. cimetidine, erythromycin, clarithromycin, ketoconazole, itraconazole. Adhesion. The adhesion potential of Alora was evaluated in a. The placebos. were applied twice weekly for 4 weeks on the lower quadrant of the abdomen. It. should be noted that the lower abdomen, the upper quadrant of the buttocks or outer. Alora. Subjects. were instructed not to do strenuous activities, take baths, use hot tubs or. In 9. 68 observations, there was a partial or complete adhesion rate of approximately. The total detachment rate was approximately 3%. Adhesion potentials of the. Only women. having estradiol and FSH serum concentrations in the postmenopausal range and. Patients received Alora 0. Alora 0. 1 mg/day and a placebo system, or two placebo systems. Measures of efficacy included mean. Alora was shown to be statistically better than placebo at Weeks. Table 3) and severity of. Table 3 : Mean Change from Baseline in. Frequency of Moderate to Severe Vasomotor Symptoms for Alora Compared to. Placebo (ITT). Week of Therapy. Mean Change from Baseline. Alora 0. 0. 5 mg/day N = 8. Baseline = 9. 0Alora 0. N = 9. 1 Baseline = 8. Placebo N = 9. 0 Baseline = 9. Indicates statistically significant differences between. Alora and placebo using an ANCOVA model adjusting for. Effects On Vulvar And Vaginal Atrophy. Vaginal cytology was obtained pre- dosing and at last. Alora 0. 0. 5 mg/day, in 4. Alora 0. 1 mg/day, and in 4. Superficial. cells increased by a mean of 1. Alora 0. 0. 5. mg/day, Alora 0. Corresponding. reductions in basal/parabasal and intermediate cells were also observed. Effects On Bone Mineral Density. Lumbar spine bone mineral density (BMD) was measured by. DEXA in a 2- year, randomized, multi- center, doubleblind, placebo- controlled. T- scores > - 2. Three Alora doses (0. BMD from baseline to Year 2. The systems were applied every 3 or 4 days on. All patients received 1. The average baseline lumbar spine T- score was - 0. The % changes in BMD from baseline are illustrated in. Figure 3. Figure 3: Mean % change in BMD from baseline at. Placebo and Alora 0. LOCF). A total of 1. All Alora doses were statistically superior to. BMD from baseline. The mean. 2- year (LOCF) percent changes in BMD for 0. Women's Health Initiative Studies. The Women's Health Initiative (WHI) enrolled a total of. CE) per day alone. MPA) per day compared to placebo in the prevention of certain chronic. The primary endpoint was the incidence of coronary heart disease. CHD) . A “global index” included the. CHD, invasive breast cancer, stroke, pulmonary embolism. PE), endometrial cancer, colorectal cancer, hip fracture, or death due to. The study did not evaluate the effects of CE or CE/MPA on. The CE/MPA substudy was stopped early because, according to. Results of the CE/MPA substudy, which included 1. White, 6. 5% Black, 5. Hispanic), after. Table 4 below: Table 4: Relative and Absolute Risk Seen in the. CE/MPA Substudy of WHIa. Eventc. Relative Risk CE/MPA vs. The absolute excess risk of events. There was no. difference between the groups in terms of all- cause mortality . The. relative risk of probable dementia in the hormone therapy group was 2. CI, 1. 2. 1 to 3. Differences between groups became apparent. It is unknown whether these findings apply to.
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