What is Zoely - Contraceptive Pill?
Zoely is a medicine available in the form of 24 white "active" tablets containing the active substances nomegestrol acetate (2.5 mg) and estradiol (1.5 mg), and 4 yellow "inactive" tablets (placebo) without active ingredients.
What is Zoely used for - Pills?
Zoely is a contraceptive pill. The medicine can only be obtained with a prescription.
How is Zoely used - Contraceptive Pill?
You take one tablet a day for as long as you want the contraceptive effect, starting with taking an active tablet on the first day of your menstrual cycle. Zoely is available in packs of 28 tablets (24 white tablets followed by 4 yellow tablets), which must be taken in sequence using the adhesive labels to mark the days of the week corresponding to each tablet.
How does Zoely - Birth Control Pills?
Zoely is a combined contraceptive pill containing two active ingredients, nomegestrol acetate (a progestin) and estradiol (an estrogen). Estradiol is identical to the hormone produced naturally by the ovaries during the menstrual cycle. Nomegestrol acetate is derived from the hormone called progesterone, also produced by the ovaries during the menstrual cycle. Zoely works by modifying the body's hormonal balance to prevent ovulation, altering the cervical mucus and thinning the endometrium (the inner lining of the uterus).
What studies have been carried out on Zoely - Pills?
The effects of Zoely were first tested in experimental models before being studied in humans.
Zoely was analyzed in two main studies involving a total of 4 433 women aged between 18 and 50 years. The women participating in the studies were treated with Zoely or another contraceptive pill containing drospirenone and ethinyl estradiol for one year (13 menstrual cycles). The main measure of effectiveness was the number of pregnancies recorded in women between the ages of 18 and 35 during treatment or shortly after its interruption, expressed in terms of the percentage of pregnancies using the "Pearl Index". The Pearl index is a standard method used to measure the effectiveness of contraceptives, which reports the number of unwanted pregnancies that occur in 100 women / years (equal to 1 300 menstrual cycles). A low Pearl Index represents a reduced probability of pregnancy.
There are no clinical study data available for Zoely on adolescents under the age of 18 years.
What benefit has Zoely - Contraceptive Pill shown during the studies?
In women aged 18-35, the Pearl index was around 0.4 with Zoely and 0.8 with the comparator in the first study, and around 1.2 with Zoely and 1.9 with the medicine of comparison in the second study.
What is the risk associated with Zoely - Pills?
The most common side effects of Zoely (seen in more than 1 in 10 subjects) are acne and changes in the menstrual cycle (for example, absence or irregularity of the cycle). For the full list of all side effects reported with Zoely, see the Package Leaflet.
Zoely must not be used in women who are hypersensitive (allergic) to nomegestrol acetate, estradiol or any of the other ingredients. It must also not be used in a woman who has or has had venous or arterial thrombosis (blood clots in the veins or arteries), including a heart attack or stroke or who suffers from conditions that can increase the risk of thrombosis (very high blood pressure, diabetes with vascular complications or very high levels of cholesterol). It should not be used in women who have a bleeding disorder (for example, a protein C deficiency), a type of migraine called "migraine with aura" (visual or other symptoms), serious problems affecting the liver as a result of which the liver does not yet function properly, certain types of tumors or abnormal blood loss from the genital area of unknown origin. For the complete list of limitations, see the package leaflet.
Why has Zoely been approved - Pills?
The CHMP decided that Zoely's benefits are greater than its risks and recommended that it be given marketing authorization.
More information on Zoely - Contraceptive Pill
The European Commission granted a marketing authorization valid throughout the European Union to Zoely Serene Europe Limited on 27 July 2011 to Merck Serono Europe Limited. The marketing authorization is valid for five years, after which it can be renewed.
For more information on Zoely therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 04-2011
