Basic Drug Info
Drug Name:Lo/Ovral
Manufacturer:Wyeth Laboratories
Other Info:

The following noncontraceptive health benefits related to the use of oral contraceptives are supported by epidemiological studies which largely utilized oral-contraceptive formulations containing doses exceeding 0.035 mg of ethinyl estradiol or 0.05 mg of mestranol.

Effects on menses:  Increased menstrual cycle regularity  Decreased blood loss and decreased incidence of iron-deficiency anemia  Decreased incidence of dysmenorrhea  Effects related to inhibition of ovulation: Decreased incidence of functional ovarian cysts  Decreased incidence of ectopic pregnancies  Effects from long-term use: Decreased incidence of fibroadenomas and fibrocystic disease of the breast  Decreased incidence of acute pelvic inflammatory disease  Decreased incidence of endometrial cancer  Decreased incidence of ovarian cancer

Clinical Trials:

Indications and Usage

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 I 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, the IUD, and implants depends upon the reliability with which they are used.

Correct and consistent use of methods can result in lower failure rates.

Table I: Percentage Of Women Experiencing An Unintended Pregnancy During The First Year Of Typical Use And The First Year Of Perfect Use Of Contraception And The Percentage Continuing Use At The End Of The First Year.

United States.

% of Women Experiencing anUnintended Pregnancy within the FirstYear of Use % of Women Continuing Use at One Year 3 Method(1)Typical Use 1(2) Perfect Use 2(3) (4) Lactation Amenorrhea Method: LAM is a highly effective, temporary method of contraception.9 Source: Trussell J.

Contraceptive efficacy.

In: Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowel D, Guest F.

Contraceptive Technology: Seventeenth Revised Edition.

New York NY: Irvington Publishers; 1998.

1. Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.

2. Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.

3. Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.

4. The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant.

Among such populations, about 89% become pregnant within one year.

This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether.

5. Foams, creams, gels, vaginal suppositories, and vaginal film.

6. Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.

7. With spermicidal cream or jelly.

8. Without spermicides.

9. However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age.

Chance 485 85 Spermicides 526 6 40 Periodic abstinence 25 63     Calendar 9     Ovulation Method 3     Sympto-Thermal 62     Post-Ovulation 1 Cap 7     Parous Women 40 26 42     Nulliparous Women 20 9 56 Sponge     Parous Women 40 20 42     Nulliparous Women 20 9 56 Diaphragm 720 6 56 Withdrawal 19 4 Condom 8     Female (Reality) 21 5 56     Male 14 3 61 Pill 5 71     Progestin only 0.5     Combined 0.1 IUD     Progesterone T 2.0 1.5 81     Copper T380A 0.8 0.6 78     LNg 20 0.1 0.1 81 Depo-Provera®0.3 0.3 70 LevonorgestrelImplants (Norplant®) 0.05 0.05 88 Female Sterilization 0.5 0.5 100 Male Sterilization 0.15 0.10 100
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 (current or history)  Thrombogenic valvulopathies  Thrombogenic rhythm disorders  Major surgery with prolonged immobilization  Diabetes with vascular involvement  Headaches with focal neurological symptoms  Uncontrolled hypertension  Known or suspected carcinoma of the breast or personal history of breast cancer  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 Lo/Ovral
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 --

Vascular Diseases -- Pathological processes involving any of the BLOOD VESSELS in the cardiac or peripheral circulation. They include diseases of ARTERIES; VEINS; and rest of the vasculature system in the body.

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

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.

Vascular Headache -- Secondary headache disorders attributed to a variety of cranial or cervical vascular disorders, such as BRAIN ISCHEMIA; INTRACRANIAL HEMORRHAGES; and CENTRAL NERVOUS SYSTEM VASCULAR MALFORMATIONS.

Neurological Signs and Symptoms --

Hypertensive disease -- Persistently high systemic arterial BLOOD PRESSURE. Based on multiple readings (BLOOD PRESSURE DETERMINATION), hypertension is currently defined as when SYSTOLIC PRESSURE is consistently greater than 140 mm Hg or when DIASTOLIC PRESSURE is consistently 90 mm Hg or more.

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)

Breast Carcinoma -- (brest KAN-ser) Cancer that forms in tissues of the breast, usually the ducts (tubes that carry milk to the nipple) and lobules (glands that make milk). It occurs in both men and women, although male breast cancer is rare.

Malignant neoplasm of breast -- A primary or metastatic malignant neoplasm involving the breast. The vast majority of cases are carcinomas arising from the breast parenchyma or the nipple. Malignant breast neoplasms occur more frequently in females than in males. -- 2003

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.

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