"The U.S. Food and Drug Administration today approved Osphena (ospemifene) to treat women experiencing moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy due to menopause.
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.
In a 12-week clinical trial, 209 postmenopausal women with vasomotor symptoms were treated with ENJUVIA (synthetic conjugated estrogens, b) . Adverse events that occurred in the study at a rate greater than or equal to 5% and greater than placebo, regardless of relationship to study drug, are summarized in Table 8.
Table 8. ENJUVIA (synthetic conjugated estrogens, b) Tablets - Number (%) of Patients Reporting Aderse Events* with ≥ 5% Occurrence Rate by Body System
|Body System/Adverse Event*|| 0.3 mg
| 0.625 mg
| 1.25 mg
|Number of Patients in Safety Sample (%)||68 (100)||72 (100)||69 (100)||72 (100)|
|Number of Patients with Adverse Events (%)||49 (72)||55 (76)||56 (81)||51 (71)|
|Number of Patients without Adverse Events (%)||19 (28)||17 (24)||13 (19)||21 (29)|
|Body as a Whole|
|Abdominal Pain||3 (4)||11 (15)||3 (4)||7 (10)|
|Accidental Injury||6 (8)||2 (3)||3 (4)||5 (7)|
|Flu Syndrome||4 (6)||3 (4)||5 (7)||3 (4)|
|Headache||10 (15)||18 (25)||11 (16)||15 (21)|
|Pain||10 (15)||14 (19)||7 (10)||6 (8)|
|Flatulence||3 (4)||5 (7)||3 (4)||2 (3)|
|Nausea||5 (7)||7 (10)||8 (12)||6 (8)|
|Dizziness||5 (7)||3 (4)||1 (1)||3 (4)|
|Paresthesia||0||4 (6)||1 (1)||0|
|Bronchitis||0||3 (4)||5(7)||3 (4)|
|Rhinitis||3 (4)||4 (6)||5 (7)||4 (6)|
|Sinusitis||2 (3)||3 (4)||5 (7)||2 (3)|
|Breast Pain||0||9 (12)||10 (14)||3 (4)|
|Dysmenorrhea||1 (2)||6 (8)||1 (1)||2 (3)|
|Vaginitis||1 (2)||5 (7)||2 (3)||3 (4)|
|*Treatment-emergent adverse events, regardless of relationship to study drug|
In a second 12-week clinical trial, 310 women with symptoms of vulvar and vaginal atrophy were treated (154 women with ENJUVIA (synthetic conjugated estrogens, b) 0.3 mg tablets and 156 women with placebo). The only adverse event that occurred at a rate of > 5% was headache; seven patients (4.55%) with ENJUVIA (synthetic conjugated estrogens, b) and twelve patients (7.69%) with placebo.
1. Genitourinary system
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; ovarian cancer; endometrial hyperplasia; endometrial cancer.
Retinal vascular thrombosis, intolerance to contact lenses.
7. Central Nervous System
Increase or decrease in weight; reduced carbohydrate tolerance; aggravation of porphyria; edema; arthralgias; leg cramps; changes in libido; urticaria, angioedema, anaphylactoid/anaphylactic reactions; hypocalcemia; exacerbation of asthma; increased triglycerides.
Read the Enjuvia (synthetic conjugated estrogens, b) 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 antigen, VIII coagulant activity, IX, X, XII, VII-X complex, II-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), sex hormone binding globulin (SHBG)) leading to increased total circulating corticosteroids and sex steroids, respectively. Free hormone concentrations may be decreased. Other plasma proteins may be increased (angiotensinogen/renin substrate, alpha-1-antitrypsin, ceruloplasmin).
- Increased plasma HDL and HDL2 cholesterol subfraction concentrations, reduced LDL cholesterol concentration, increased triglyceride levels.
- Impaired glucose tolerance.
- Reduced response to metyrapone test.
Read the Enjuvia Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 8/7/2007
This monograph has been modified to include the generic and brand name in many instances.
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