IOA - Contraceptive Pill

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What is IOA - Contraceptive Pill?

IOA is a medicine available in 24 white "active" tablets containing the active ingredients nomegestrol acetate (2.5 mg) and estradiol (1.5 mg) as well as four yellow "inactive" tablets that do not contain any active ingredient.

What is IOA - Contraceptive Pill used for?

IOA is a contraceptive pill. The medicine can only be obtained with a prescription.

How is IOA - Contraceptive Pill used?

One tablet a day should be taken for the period for which contraception is needed, starting with an active tablet on the first day of the cycle. IOA is presented in blisters of 28 tablets (24 white tablets followed by 4 yellow tablets), taken in sequence using markers to identify the days of the week for each tablet.

How does IOA - Contraceptive Pill work?

IOA is a contraceptive pill composed of two active ingredients, nomegestrol acetate (a progesterone) and estradiol (an estrogen). Estradiol is analogous to a hormone naturally produced by the ovaries during the menstrual cycle. Nomegestrol acetate is derived from the hormone called progesterone, also produced by the ovaries during a menstrual cycle. IOA acts by varying the body's hormonal balance to prevent ovulation, altering the cervical mucus and thinning the endometrium (internal lining of the uterus).

What studies have been carried out on IOA - Contraceptive Pill?

Before being studied in humans, the effects of IOA were analyzed in experimental models.

IOA was examined in two main studies involving 4, 433 women between 18 and 50 years of age. Participants were given both IOA and another contraceptive pill containing drospirenone and ethinyl estradiol for one year (13 menstrual cycles). The main measure of effectiveness was the number of women between 18 and 35 years of age who became pregnant during or shortly after the treatment, expressed in terms of pregnancy using the "Pearl indices". The Pearl index is a standard way of measuring the effectiveness of contraceptives, which measures how many unwanted pregnancies occur in 100 women-years (corresponding to 1, 300 menstrual cycles). A low Pearl Index represents a lower opportunity to be pregnant.

No data are available on IOA in adolescents under the age of 18 years.

What benefits has IOA - Contraceptive Pill demonstrated?

In women between 18 and 35 years of age the Pearl index was approximately 0.4 for IOA and 0.8 for the comparator drug in the first study, and about 1.2 for IOA and to 1.9 for the comparator drug in the second study.

What is the risk associated with IOA - Birth Control Pills?

The most frequent side effects with IOA (seen in more than 1 user in 10) are acne and change in menstrual periods (ie absence or irregularity). For the full list of all side effects reported with IOA, see the package leaflet.

IOA should not be used in women who may be hypersensitive (allergic) to nomegestrol acetate, estradiol or any of the other ingredients. It must not be used by women who have, or have had, venous or arterial thrombosis (blood clots in the veins or arteries), including stroke or heart attacks or who have certain risk factors for thrombosis (very high blood pressure, diabetes with damage to the blood vessels, high cholesterol levels). It must not be used in women who experience a blood clotting disorder (such as protein C deficiency), migraine with aura (visual or other symptoms), severe liver problems with the liver that does not function normally, certain types of cancer or abnormal bleeding of the genital area whose cause has not been diagnosed. For the full list of usage restrictions, see the package leaflet.