"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.
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Details with Side Effects
Because clinical trials are conducted under widely varying conditions, adverse event 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.
EstroGel (estradiol gel) 1.25 g was studied in 2 well-controlled 12-week clinical trials. Incidence of adverse events ≥ 5 percent for 1.25 g EstroGel (estradiol gel) and placebo is given below in Table 4.
TABLE 4: Incidence of Treatment-emergent Signs and Symptoms
≥ 5 Percent By COSTART Body System and by Descending Frequency of Occurrence
in the EstroGel (estradiol gel) Treatment Group for the Intent-to-Treat Safety Population in
2 Well-controlled Clinical Studies (Expressed as Percent of Treatment Group)
| Body System/Treatment-emergent
Signs and Symptoms
| EstroGel 1.25 g day
|BODY AS A WHOLE|
|METABOLIC and NUTRITIONAL SYSTEMS|
|SKIN AND APPENDAGES|
|Pap smear suspicious||||5.4||2.7|
| *Infection: upper respiratory infection, common cold, eye
†Pain: generalized and extremity aches/pains, cramps.
‡Rash and pruritus: more than half of the EstroGel (estradiol gel) -treated patients who had pruritus reported itching at a body site other than the arms or reported generalized itching or itching skin. Similarly, most of the EstroGel (estradiol gel) -treated patients with rash had rash on 1 or more areas of the body in addition to the arms.
§Endometrial disorder: proliferative endometrium, benign endometrial disorders.
|| Pap smear suspicious: atypical squamous cells of undetermined significance, inflammatory changes, epithelial cell abnormality.
- Genitourinary system: abnormal uterine bleeding/spotting; dysmenorrhea/pelvic pain; 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
- Breasts: tenderness; enlargement; pain; nipple discharge; galactorrhea; fibrocystic breast changes; breast cancer
- Cardiovascular: deep and superficial venous thrombosis; pulmonary embolism; thrombophlebitis; myocardial infarction; stroke; increase in blood pressure
- Gastrointestinal: nausea; vomiting, abdominal cramps; bloating; cholestatic jaundice; increased incidence of gallbladder disease; pancreatitis; enlargement of hepatic hemangiomas
- Skin: chloasma or melasma, that may persist when drug is discontinued; erythema multiforme; erythema nodosum; hemorrhagic eruption; loss of scalp hair; hirsutism; pruritus; rash
- Eyes: retinal vascular thrombosis; intolerance to contact lenses
- Central nervous system: headache; migraine; dizziness; mental depression; exacerbation of chorea; nervousness; mood disturbances; irritability; exacerbation of epilepsy; dementia
- Miscellaneous: increase or decrease in weight; glucose intolerance; aggravation of porphyria; edema; arthralgias; leg cramps; changes in libido; urticaria; angioedema; anaphylactoid/anaphylactic reactions; hypocalcemia (preexisting condition); exacerbation of asthma; increased triglycerides
Read the EstroGel (estradiol gel) Side Effects Center for a complete guide to possible side effects
- 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) 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 T3 concentrations are unaltered. Patients on thyroid-replacement therapy may require higher doses of thyroid hormone.
- Other binding proteins may be elevated in serum (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.
Last reviewed on RxList: 2/12/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional EstroGel Information
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