Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.Oral contraceptives are highly effective.

Table II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception.

The efficacy of these contraceptive methods, except sterilization and the IUD, depends upon the reliability with which they are used.

Correct and consistent use of methods can result in lower failure rates. TABLE II: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF USE OF A CONTRACEPTIVE METHOD NA - not available * Depending on method (calendar, ovulation, symptothermal, post-ovulation) Adapted from Hatcher RA et al, Contraceptive Technology: 17th Revised Edition.

NY, NY: Ardent Media, Inc., 1998 ? MethodPerfect UseTypical Use Levonorgestrel implants0.050.05 Male sterilization0.10.15 Female sterilization0.50.5 Depo-Provera®     (injectable progestogen)0.30.3 Oral contraceptives5     Combined0.1NA     Progestin only0.5NA IUD     Progesterone1.52.0     Copper T 380A0.60.8 Condom (male) without spermicide314     (Female) without spermicide521 Cervical cap     Nulliparous women920     Parous women2640 Vaginal sponge     Nulliparous women920     Parous women2040 Diaphragm with     spermicidal cream or jelly620 Spermicides alone   (foam, creams, jellies, and vaginal suppositories)626 Periodic abstinence (all methods)1-9*25 Withdrawal419 No contraception (planned pregnancy)8585

Combination oral contraceptives should not be used in women with any of the following conditions:Thrombophlebitis or thromboembolic disorders.A past history of deep-vein thrombophlebitis or thromboembolic disorders.Cerebral-vascular or coronary-artery disease.Thrombogenic valvulopathies.Thrombogenic rhythm disorders.Diabetes with vascular involvement.Uncontrolled hypertension.Known or suspected carcinoma of the breast.Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia.Undiagnosed abnormal genital bleeding.Cholestatic jaundice of pregnancy or jaundice with prior pill use.Hepatic adenomas or carcinomas, or active liver disease, as long as liver function has not returned to normal.Known or suspected pregnancy.Hypersensitivity to any of the components of Trivora (levonorgestrel and ethinyl estradiol tablets–triphasic regimen).

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Thrombophlebitis -- Inflammation of a vein associated with a blood clot (THROMBUS).

Thromboembolism -- Obstruction of a blood vessel (embolism) by a blood clot (THROMBUS) in the blood stream.

Deep thrombophlebitis --

Coronary Artery Disease -- Pathological processes of CORONARY ARTERIES that may derive from a congenital abnormality, atherosclerotic, or non-atherosclerotic cause.

Disease -- A definite pathologic process with a characteristic set of signs and symptoms. It may affect the whole body or any of its parts, and its etiology, pathology, and prognosis may be known or unknown.

Diabetes --

Diabetes Mellitus -- A heterogeneous group of disorders characterized by HYPERGLYCEMIA and GLUCOSE INTOLERANCE.

Diabetes Mellitus, Non-Insulin-Dependent -- subclass of diabetes mellitus that is not insulin responsive or dependent; characterized initially by insulin resistance and hyperinsulinemia and eventually by glucose intolerance, hyperglycemia, and overt diabetes; type II diabetes mellitus is no longer considered a disease exclusively found in adults; patients seldom develop ketosis but often exhibit obesity.

Carcinoma -- A malignant neoplasm made up of epithelial cells tending to infiltrate the surrounding tissues and give rise to metastases. It is a histological type of neoplasm but is often wrongly used as a synonym for "cancer." (From Dorland, 27th ed)

Obstructive Jaundice -- JAUNDICE, the condition with yellowish staining of the skin and mucous membranes, that is due to impaired BILE flow in the BILIARY TRACT, such as INTRAHEPATIC CHOLESTASIS, or EXTRAHEPATIC CHOLESTASIS.

Icterus -- A clinical manifestation of HYPERBILIRUBINEMIA, characterized by the yellowish staining of the SKIN; MUCOUS MEMBRANE; and SCLERA. Clinical jaundice usually is a sign of LIVER dysfunction.

Hepatic adenoma --

Liver diseases -- Pathological processes of the LIVER.

Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Cigarette smoking increases the risk of serious cardiovascular side effects from oral-contraceptive use.

This risk increases with age and with the extent of smoking (in epidemiologic studies, 15 or more cigarettes per day was associated with a significantly increased risk) and is quite marked in women over 35 years of age.

Women who use oral contraceptives should be strongly advised not to smoke. The use of oral contraceptives is associated with increased risks of several serious conditions including venous and arterial thrombotic and thromboembolic events (such as myocardial infarction, thromboembolism, and stroke), hepatic neoplasia, gallbladder disease, and hypertension, although the risk of serious morbidity or mortality is very small in healthy women without underlying risk factors.

The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors such as certain inherited or acquired thrombophilias, hypertension, hyperlipidemias, obesity, and diabetes.Practitioners prescribing oral contraceptives should be familiar with the following information relating to these risks.The information contained in this package insert is based principally on studies carried out in patients who used oral contraceptives with higher formulations of estrogens and progestogens than those in common use today.

The effect of long-term use of the oral contraceptives with lower formulations of both estrogens and progestogens remains to be determined.Throughout this labeling, epidemiological studies reported are of two types: retrospective or case control studies and prospective or cohort studies.

Case control studies provide a measure of the relative risk of disease, namely, a ratio of the incidence of a disease among oral-contraceptive users to that among nonusers.

The relative risk does not provide information on the actual clinical occurrence of a disease.

Cohort studies provide a measure of attributable risk, which is the difference in the incidence of disease between oral-contraceptive users and nonusers.

The attributable risk does provide information about the actual occurrence of a disease in the population.

For further information, the reader is referred to a text on epidemiological methods.