"Oct. 24, 2012 -- Women who take hormones within five years of menopause may have a slightly lower risk of Alzheimer's disease compared to women who don't ever take them, a new study shows.
The study, which is published in the journal"...
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.
Adverse events reported with Activella (estradiol, norethindrone acetate) 1.0 mg/0.5 mg by investigators in the Phase 3 studies regardless of causality assessment are shown in Table 6.
TABLE 6: ALL TREATMENT-EMERGENT ADVERSE EVENTS REGARDLESS
OF RELATIONSHIP REPORTED AT A FREQUENCY OF ≥ 5% WITH ACTIVELLA (estradiol, norethindrone acetate) 1.0 MG/0.5 MG
|Endometrial Hyperplasia Study (12-Months)||Vasomotor Symptoms Study (3-Months)||Osteoporosis Study (2years)|
|Activella 1.0 mg/0.5 mg
|1 mg E2
|Activella 1.0 mg/0.5 mg
|Activella (estradiol, norethindrone acetate)
1.0 mg/0.5 mg
|Body as a Whole|
|Upper Respiratory Tract Infection||18%||15%||10%||6%||15%||19%|
|Metabolic and Nutritional|
|* including one upper extremity fracture in each group|
Adverse events reported with Activella (estradiol, norethindrone acetate) 0.5 mg/0.1 mg by investigators during the Phase 3 study regardless of causality assessment are shown in Table 7.
TABLE 7: ALL TREATMENT-EMERGENT ADVERSE EVENTS REGARDLESS
OF RELATIONSHIP REPORTED AT A FREQUENCY OF ≥ 5% WITH ACTIVELLA (estradiol, norethindrone acetate) 0.5 MG/0.1 MG
|Activella 0.5 mg/0.1 mg
|Body as a Whole|
|Pain in extremity||5%||4%|
The following adverse reactions have been reported with estrogen and/or progestin therapy:
Changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow; breakthrough bleeding; spotting; dysmenorrhea, increase in size of uterine leiomyomata; vaginitis, including vaginal candidiasis; change in amount of cervical secretion; changes in cervical ectropion; premenstrual-like syndrome; cystitis-like syndrome; ovarian cancer; endometrial hyperplasia; endometrial cancer.
Retinal vascular thrombosis, intolerance to contact lenses.
Central nervous system
Increase or decrease in weight; aggravation of porphyria; edema; leg cramps; changes in libido; fatigue; reduced carbohydrate tolerance; anaphylactoid/anaphylactic reactions; hypocalcemia; exacerbation of asthma; increased triglycerides; back pain; arthralgia; myalgia.
Read the Activella (estradiol, norethindrone acetate) Side Effects Center for a complete guide to possible side effects »
Drug/Laboratory Test Interactions
- Accelerated prothrombin time, partial thromboplastin time, and platelet aggregation time; increased platelet count; increased factors II, VII antigen, VIII coagulant activity, IX, X, XII, VII-X complex, and beta-thromboglobulin; decreased levels of anti-factor Xa and antithrombin III, decreased antithrombin III activity, increased levels of fibrinogen and fibrinogen activity; increased plasminogen antigen and activity.
- Increased thyroid-binding globulin (TBG) levels leading to increased circulating total thyroid hormone levels as measured by protein-bound iodine (PBI), T4 levels (by column or by radioimmunoassay), or T3 levels by radioimmunoassay. T3 resin uptake is decreased, reflecting the elevated TBG. Free T4 and free T3 concentrations are unaltered. Patients on thyroid replacement therapy may require higher doses of thyroid hormone.
- Other binding proteins may be elevated in serum (i.e., corticosteroid binding globulin (CBG), SHBG) leading to increased total circulating corticosteroids and sex steroids, respectively. Free hormone concentrations may be decreased. Other plasma proteins may be increased (angiotensinogen/rennin substrate, alpha-1 antitrypsin, ceruloplasmin).
- Increased plasma HDL and HDL2cholesterol subfraction concentration, reduced LDL cholesterol concentration, increased triglyceride levels.
- Impaired glucose tolerance.
- Reduced response to metyrapone test.
Last reviewed on RxList: 9/29/2008
This monograph has been modified to include the generic and brand name in many instances.
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