Novaring ring vaginal sachet N3
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Active ingredients
Etonogestrel + Ethinyl Estradiol
Composition
1 ring vaginal: ethinyl estradiol 2.7 mg; etonogestrel 11.7 mg. Auxiliary substances: ethylene and vinyl acetate copolymer (28% vinyl acetate) - 1677 mg, ethylene and vinyl acetate copolymer (9% vinyl acetate) - 197 mg, magnesium stearate - 1.7 mg.
Pharmacological effect
Combined hormonal contraceptive drug containing etonogestrel and ethinyl estradiol. Etonogestrel is a progestogen (a derivative of 19-nortestosterone), which binds to progesterone receptors in target organs with high affinity. Ethinyl estradiol is an estrogen and is widely used for the manufacture of contraceptives. Contraceptive effect of the drug Novara; due to a combination of various factors, the most important of which is the suppression of ovulation. Efficiency: In clinical studies, it was found that the Pearl index (an indicator reflecting the pregnancy rate in 100 women during 1 year of contraception) in women aged 18 to 40 years for drug Novaring; amounted to 0.96 (95% CI: 0.64-1.39) and 0.64 (95% CI: 0.35-1.07) with a statistical analysis of all randomized participants (ITT-analysis) and analysis of participants of the studies who completed them according to the protocol (PP-analysis), respectively. These values were similar to the values of Pearl indexes obtained in comparative studies of combined oral contraceptives (CPC) containing levonorgestrel / ethinyl estradiol (0.150 / 0.030 mg) or drospirenone / ethinyl estradiol (3 / 0.30 mg). Against the background of the use of the preparation Noving Ring; the cycle becomes more regular, pain and intensity of menstrual-like bleeding decrease, which helps to reduce the incidence of iron deficiency. There is evidence of a reduction in the risk of endometrial and ovarian cancer with the use of the drug. Character of bleeding: Comparison of the characteristics of the nature of bleeding over the course of one year in 1000 women who used the preparation NovaRing; and PDA containing levonorgestrel / ethinyl estradiol (0.150 / 0.030 mg) showed a significant decrease in the frequency of breakthrough bleeding or spotting when using the preparation NovaraRing; compared to the PDA.In addition, the frequency of cases where bleeding occurred only during a break in the use of the drug was significantly higher among women who used the novaring drug. The effect on bone mineral density: a comparative two-year study of the effect of the novaRing (n = 76) and non-hormonal intrauterine spiral ( n = 31) showed no effect on bone mineral density in women. Children: The safety and efficacy of NovaRing; for teenage girls under the age of 18 years has not been studied.
Pharmacokinetics
Etonogestrel. Absorption: Etonogestrel released from the NovaRing vaginal ring is rapidly absorbed through the vaginal mucosa. Cmax of etonogestrel in plasma, amounting to about 1700 pg / ml, is reached approximately 1 week after the administration of the ring. Plasma concentration varies in a small range and slowly decreases to about 1600 pg / ml after 1 week, 1500 pg / ml after 2 weeks and 1400 pg / ml after 3 weeks of use. Absolute bioavailability is about 100%, which exceeds the oral bioavailability of etonogestrel. According to the results of measurements of concentrations of etonogestrel in the cervix and inside the uterus in women using NovaRing, and women using oral contraceptives containing 0.150 mg of desogestrel and 0.020 mg of ethinyl estradiol, the observed values of concentrations of etonogestrel were comparable. and sex hormone-binding globulin (SHBG). The apparent Vd of etonogestrel is 2.3 l / kg. Metabolism: The biotransformation of etonogestrel occurs through the known metabolism of sex hormones. The apparent plasma clearance is about 3.5 l / h. Direct interaction with ethinyl estradiol, taken at the same time, was not detected. Introduction: The concentration of etonogestrel in the blood plasma decreases in two phases. In the terminal phase, T1 / 2 is about 29 hours. Etonogestrel and its metabolites are excreted by the kidneys and through the intestine with bile in a ratio of 1.7: 1. The T1 / 2 metabolite is about 6 days. Ethinyl estradiol. Absorption: Ethinyl estradiol, released from the vaginal ring Novaring; quickly absorbed through the vaginal mucosa. Cmax in plasma, amounting to about 35 pg / ml, is reached after 3 days after injection of the ring and decreases to 19 pg / ml after 1 week, to 18 pg / ml after 2 weeks and 18 pg / ml after 3 weeks of use. Absolute bioavailability is approximately 56% and is comparable to oral ethinyl estradiol.According to the results of measurements of the concentrations of ethinyl estradiol in the cervix and inside the uterus in women using NovaRing; and women using oral contraceptives containing 0.150 mg of desogestrel and 0.020 mg of ethinyl estradiol, the observed values of ethinyl estradiol concentrations were comparable. Ethyl estradiol concentration was monitored. drug Novaring; (daily release of ethinyl estradiol in the vagina of 0.015 mg), transdermal patch (norelgestromin / ethinyl estradiol; daily release of ethinyl estradiol of 0.020 mg) and PDA (levonorgestrel / ethinyl estradiol; daily release of ethinyl estradiol of 0.030 mg), in the case of the daily release of ethinyl estradiol of 0.030 mg), for the use of ethinyl estradiol, 0.030 mg, 0.20 mg, 0.21 mg in the vagina; Systemic exposure to ethinyl estradiol for a month (AUC0-∞) for the preparation Novara; was statistically significantly lower than that of the patch and PDA, and amounted to 10.9, 37.4 and 22.5 ngch / ml, respectively. Distribution: Ethinyl estradiol is associated with serum albumin. Apparent Vd is about 15 l / kg. Metabolism: Ethinyl estradiol is metabolized by aromatic hydroxylation. During its biotransformation, a large number of hydroxylated and methylated metabolites are formed, which circulate both in the free state and in the form of glucuronide and sulfate conjugates. The apparent clearance is about 3.5 l / h. Output: The concentration of ethinyl estradiol in plasma decreases in two phases. T1 / 2 in the terminal phase varies widely; the median is about 34 hours. Ethinyl estradiol is not displayed unchanged; its metabolites are excreted by the kidneys and through the intestines at a ratio of 1.3: 1. T1 / 2 of the metabolites is about 1.5 days. Particular groups of patients. Children; Pharmacokinetics of the preparation NovaRing; in healthy adolescent girls under the age of 18 years who already had menstruation, has not been studied. Renal impairment: The effect of kidney disease on the pharmacokinetics of the preparation NovaRing; not studied. Impaired liver function: The effect of liver disease on the pharmacokinetics of the preparation NovaraRing; has not been studied. However, in patients with impaired liver function, the metabolism of sex hormones may deteriorate. Ethnic groups: The pharmacokinetics of the drug among representatives of ethnic groups have not been specifically studied.
Indications
Contraception.
Contraindications
Thrombosis (arterial or venous) and thromboembolism at present or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders); - conditions preceding thrombosis (including transient ischemic attacks, angina pectoris) currently or in history; susceptibility to the development of venous or arterial thrombosis, including hereditary diseases: resistance to activated protein C, antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperg mocysteinemia and antiphospholipid antibodies (antibodies to cardiolipin, lupus anticoagulant); - migraine with focal neurological symptoms now or in history; - diabetes mellitus with vascular lesions; - pronounced or multiple risk factors for venous or arterial thrombosis; , myocardial infarction or impaired cerebral circulation at a young age in one of the closest relatives), arterial hypertension, valvular heart disease ca, atrial fibrillation, extended surgery, prolonged immobilization, extensive trauma, obesity (BMI> 30 kg / m2), smoking in women over 35 years old - pancreatitis (including history of) in combination with severe hypertriglyceridemia; severe liver disease; liver malignant or benign tumors (including a history); established or suspected hormone-dependent malignant tumors (for example, genitals or mammary gland); vaginal bleeding unclear etiology; - pregnancy (including intended); - breastfeeding period; - hypersensitivity to any of the active or auxiliary substances of the preparation NovaRing; .Safety and efficacy Reparata NuvaRing; for adolescent girls under the age of 18 years have not been studied. If any of the above conditions occur, discontinue use of the drug immediately. Use the drug with caution if you have any of the following diseases, conditions, or risk factors; in such cases, the physician must carefully weigh the balance between the benefits and the risk of using NovaRing ;: Contraindicated in severe liver diseases (before normalization of function indicators) .— The presence of risk factors for thrombosis and thromboembolism: a hereditary predisposition to thrombosis (myocardial infarction or cerebral blood flow at a young age in someone from the next of kin), smoking, obesity, dyslipoproteinemia, arterial hypertension, migraine without focal neurological symptoms, valvular heart disease, arrhythmias, prolonged immobilization, serious surgical procedures; superficial veins; - dyslipoproteinemia; - valvular heart disease; - adequately controlled arterial hypertension; - diabetes mellitus without vascular complications; - os three or chronic liver dysfunction; - jaundice and / or pruritus caused by cholestasis; - cholelithiasis; - porphyria; - systemic lupus erythematosus; - hemolytic-uremic syndrome; - chorea Sidenhema (minor chorea); - hearing loss due to sclerosis; - angioedema (hereditary) edema; - chronic inflammatory bowel disease (Crohn's disease and ulcerative colitis); - sickle cell anemia; - chloasma; - conditions that impede the use of the vaginal ring: prolapse of the cervix, hernia of the bladder, hernia pr rectum, severe chronic zapory.V case of aggravation of diseases, deterioration, or the occurrence of any of these conditions should first consult your doctor to decide on the possibility of further use of NuvaRing drug ;.
Use during pregnancy and lactation
Drug NovaRing; designed to prevent pregnancy. If a woman wants to stop using the drug to get pregnant, for conception it is recommended to wait for the restoration of the natural cycle, because this will help to correctly calculate the date of conception and childbirth. The use of the drug Novara; during pregnancy is contraindicated. If pregnancy occurs, the ring should be removed. Extensive epidemiological studies have not revealed an increased risk of congenital malformations in children born to women who took the CCP before pregnancy, as well as teratogenic effects in cases when women took the CCP in early pregnancy without knowing it. Although this applies to all PDAs, it is not known whether this also applies to the preparation NovaraRing;A clinical study in a small group of women showed that, despite the fact that the drug was NovaRing; is introduced into the vagina, the concentration of contraceptive hormones inside the uterus when using the drug Novarah; similar to those in the application of the CCP. The outcomes of pregnancies in women who used the drug Novairing; during the clinical study, not described. The use of the drug Noving; during breastfeeding is contraindicated. The composition of the drug can affect lactation, reduce the amount and change the composition of breast milk. Small amounts of contraceptive steroids and / or their metabolites may be excreted in breast milk, but evidence of their negative impact on children's health has not been obtained.
Dosage and administration
Novara; Injected into the vagina 1 time in 4 weeks. The ring is placed in the vagina for 3 weeks and then removed on the same day of the week on which it was placed in the vagina; after a week break, a new ring is introduced. For example: if the ring is NovaRing; was set on Wednesday at about 22.00, then it should be removed on Wednesday after 3 weeks at about 22.00; a new ring is introduced into the next Wednesday. The bleeding associated with the cessation of the action of the drug usually begins 2-3 days after the removal of NovaRing; and it may not completely stop until the new ring is installed. Hormonal contraceptives have not been used in the previous menstrual cycle: Novareng; should be entered on the first day of the cycle (ie, on the first day of menstruation). It is allowed to install the ring on the 2nd to 5th days of the cycle, however, in the first cycle in the first 7 days of the use of the preparation Novaring; additional use of barrier methods of contraception is recommended. Transfer from reception of the combined oral contraceptives: NovaRing; should be administered on the last day of the normal interval between cycles of combined hormonal contraceptive use (pills or patch). If a woman takes a combined hormonal contraceptive correctly and regularly and is sure that she is not pregnant, she can switch to using the vaginal ring on any day of the cycle. We should not exceed the recommended interval during which hormonal contraceptives are not used. progestogen (mini-drank, progestin oral contraceptives, implants, injectable forms or hormone-containing intrauterine systems - IUD) A woman who takes a mini-drank can go on and NuvaRing use of the drug; any dayThe ring is inserted on the day the implant or IUD is removed. If the woman received injections, then the use of the drug Noving; begin on the day when you had to make another injection. In all these cases, the woman should use a barrier method of contraception during the first 7 days after the injection of the ring. After an abortion made in the first trimester of pregnancy: Using Novairing; You can start immediately after the abortion. In this case, there is no need for additional use of other contraceptives. If the use of Noving; immediately after the abortion is undesirable, the use of the ring should be made in the same way as if hormonal contraceptives were not used in the previous cycle. In the interval, women are recommended to use an alternative method of contraception. After childbirth or abortion, performed in the second trimester of pregnancy: Using Novairing; should begin within the 4th week after childbirth (if the woman is not breastfeeding) or abortion in the second trimester. If the application is Noving; started later, it is necessary to use barrier contraceptive methods in the first 7 days of the use of NovaRing ;. However, if during this period sexual contact has already taken place, then before using the drug Novara; it is necessary to exclude pregnancy or wait for the first menstruation. Deviations from the recommended regimen: The contraceptive effect and control of the cycle may be disturbed if the patient does not follow the recommended regimen. In order to avoid the loss of the contraceptive effect in case of deviation from the regime, the following recommendations should be followed. Extending the interruption in the use of the ring: If you have sex during the interruption in the use of the ring, pregnancy should be excluded. The longer the break, the higher the probability of pregnancy. With the exception of pregnancy should, if possible, as soon as possible to introduce a new ring into the vagina. Within the next 7 days, an additional barrier method of contraception can be used, for example, a condom. If the ring was temporarily removed from the vagina: If the ring remained outside the vagina for less than 3 hours, the contraceptive effect will not decrease. The ring should be re-inserted into the vagina as soon as possible (no later than 3 hours). If the ring was out of the vagina for more than 3 hours during the first or second weekuse, the contraceptive effect can be reduced. It should be placed in the vagina as soon as possible. Over the next 7 days, you must use a barrier method of contraception, for example, a condom. The longer the ring has been outside the vagina and the closer this period is to a 7-day break in the use of the ring, the higher the probability of pregnancy. If the ring has been outside the vagina for more than 3 hours during the third week of use, the contraceptive effect can be reduced. A woman should discard this ring and choose one of the following two methods. Immediately install a new ring. It should be borne in mind that the new ring can be used in the next 3 weeks. At the same time there may be no bleeding associated with the cessation of the action of the drug. However, there may be spotting or bleeding in the middle of a cycle. Wait for bleeding associated with the termination of the drug, and enter a new ring no later than 7 days after the removal of the previous ring. This option should be selected only if the mode of using the ring earlier during the first 2 weeks was not violated. Extended use of the ring: If the preparation is NovRing; if a maximum period of 4 weeks was used, the contraceptive effect remains sufficient. You can take a week off to use the ring, and then introduce a new ring. If Novara; remained in the vagina for more than 4 weeks, the contraceptive effect may deteriorate, so pregnancy should be excluded before the introduction of the new ring. If the woman does not adhere to the recommended regimen, and after a week of interruption in the use of the ring, no pregnancy should be excluded. How to shift or delay the onset of menstrual bleeding: To delay menstrual-like bleeding cancel, you can enter a new ring without weeks about a break. The next ring must be used within 3 weeks. This can cause bleeding or spotting. Further, after the usual week break, one should return to the regular use of Noving ;.To postpone the onset of bleeding to another day of the week, it may be recommended to take a shorter break in the use of the ring (as many days as necessary).The shorter the break in the use of the ring, the higher the likelihood of no bleeding that occurs after removing the ring and the occurrence of bleeding or spotting during the use of the next ring. Damage to the ring In rare cases when using Novoring; there was a ring break. The core of the ring NovaRing; is solid, therefore its contents remain intact, and the release of hormones does not change significantly. In case of rupture of the ring, it usually falls out of the vagina. When the ring is broken, you must enter a new ring (in accordance with the above recommendations if the ring was temporarily removed from the vagina). Loss of ring: Sometimes loss of NovaRing was noted; from the vagina, for example, with its incorrect introduction, with the removal of a tampon, during sexual intercourse or against the background of severe or chronic constipation. In this regard, it is advisable for a woman to regularly check the presence of the ring Novara; in the vagina. In case of loss of the vaginal ring, you should follow the above recommendations if the ring was temporarily removed from the vagina. Rules for using NovRing ;: A woman can independently administer NovRing; in the vagina. To insert a ring, a woman should choose the most comfortable position for her, for example, standing, lifting one leg, squatting, or lying down. Novara; It is necessary to compress and hold the vagina to a comfortable position of the ring. The exact position of NovaRing; the vagina is not decisive for the contraceptive effect. After insertion, the ring should be in the vagina constantly for 3 weeks. If the ring was accidentally removed, it must be rinsed with warm (not hot) water and immediately inserted into the vagina. To remove the ring, you can pick it up with your index finger or squeeze between the index and middle fingers and pull it out of the vagina. The used ring should be placed in a bag (keep out of the reach of children and pets) and discarded.
Side effects
Determination of the frequency of side effects: often (≥1 / 100), infrequently (<1/100, ≥1 / 1000), rarely (<1/1000, ≥1 / 10 000). Often. Infrequently. Seldom. Data post-marketing use1Infections and invasions .Vaginal infection: Cervicitis, cystitis, urinary tract infections On the part of the immune system: Hypersensitivity. On the metabolic side: Weight gain. Increased appetite. Mental disorders: Depression, decreased libido. Mood change. From the nervous system: headache, migraine. Dizziness, hypesthesia.On the part of the organ of vision: Impaired vision. Since the cardiovascular system: Hot flashes, increased blood pressure. Venous thromboembolism 2. From the digestive system: Abdominal pain, nausea. Bloating, diarrhea, vomiting, constipation. On the part of the skin: Acne Alopecia, eczema, pruritus, rash Urticaria. On the part of the musculoskeletal system: Back pain, muscle spasms, pain in the extremities On the part of the urinary system: Dysuria, urinary urination, pollakiuria. Genital and mammary gland disorders: Breast engorgement and tenderness, genital itching in women, painful menstrual bleeding, pain in the pelvic region, vaginal discharge. No menstrual bleeding, discomfort in the mammary glands, enlargement of the mammary glands, induration in the mammary glands, polyps of the cervix, contact (during intercourse) bleeding (bleeding), painful feelings during intercourse, ectropion of the cervix, fibrocystic mastopathy , profuse menstrual bleeding, acyclic bleeding, discomfort in the pelvic region, premenstrual syndrome, burning sensation in the vagina, vaginal odor, painful sensation Vagina, discomfort and dryness of the vulva and vaginal mucosa. Local reactions at a partner3 galactorrhea. On the whole body: Fatigue, irritability, indisposition, edema. Others: Discomfort when using the vaginal ring, loss of the vaginal ring. Difficulty in using the contraceptive, rupture (damage) of the ring, foreign body sensation in the vagina. 1The list of side effects is based on data obtained from spontaneous reports. It is not possible to accurately determine the frequency.2 Observational cohort study data: ≥1 / 10,000 - <1/1000 women-years.3 Local reactions at the partner include reports of local penis reactions (eg, pain, hyperemia, bruising and abrasion). Side effects that occurred when taking combined hormonal contraceptives: pancreatitis, cholecystitis, cerebrovascular disorders, benign and malignant tumors of the liver, chloasma, changes in insulin resistance. In women with hereditary forms a gionevroticheskogo edema exogenous estrogens may induce or worsen symptoms of angioedema.
Overdose
The serious consequences of an overdose of hormonal contraceptives are not described. Estimated symptoms: nausea, vomiting, small vaginal bleeding in young girls. Treatment: conduct symptomatic therapy. There are no antidotes.
Interaction with other drugs
The interaction between hormonal contraceptives and other drugs can lead to the development of acyclic bleeding and / or ineffectiveness of contraception. The following interactions with combined oral contraceptives in general are described in the literature. Possible interactions with drugs that induce microsomal liver enzymes can result in increased clearance of sex hormones . Interaction with the following drugs was established: phenytoin, barbiturates, primidone, carbamazepine, rifampicin, and also, possibly, oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin, and preparations containing St. John's wort hollowed out. (condom) in combination with the preparation Novara; or choose a different method of contraception. During concomitant use of drugs that induce microsomal liver enzymes, and for 28 days after their withdrawal, barrier methods of contraception should be used. If concomitant therapy should be continued after 3 weeks of use of the ring, the next ring should be entered immediately without the usual interval. The effectiveness of oral contraceptives containing ethinyl estradiol has been reported with the concomitant use of antibiotics such as ampicillin and tetracyclines. The mechanism of this effect has not been studied. In the study of pharmacokinetic interaction, oral administration of amoxicillin (875 mg 2 times / day) or doxycycline (200 mg / day, and then 100 mg / day) for 10 days during the use of the preparation NovaraRing; had little effect on the pharmacokinetics of etonogestrel and ethinyl estradiol. When using antibiotics (excluding amoxicillin and doxycycline), you should use a barrier method of contraception (condom) during treatment and for 7 days after discontinuation of antibiotics.If concomitant therapy is to be continued after a 3-week use of the ring, then the next ring should be entered immediately without the usual interval. Pharmacokinetic studies did not reveal the effect of the simultaneous use of antifungal agents and spermicides on the contraceptive efficacy and safety of Novaring; With the combined use of suppositories with antifungal drugs slightly increases the risk of ring rupture. Hormonal contraceptives can cause disruption of the metabolism of other drugs. Accordingly, their concentrations in plasma and tissues may increase (for example, cyclosporine) or decrease (for example, lamotrigine). To eliminate possible interactions, it is necessary to study the instructions for use of other drugs. Pharmacokinetic data show that the use of tampons does not affect the absorption of hormones released from the vaginal ring NovaRing ;. In rare cases, the ring may be accidentally removed when removing the tampon.
special instructions
If any of the diseases, conditions, or risk factors listed below are present, the benefit of using NovaRing should be evaluated; and the possible risks for each individual woman before she starts using the drug Novara ;. In the case of exacerbation of diseases, deterioration or the occurrence of any of the following conditions, for the first time a woman should consult a doctor to decide whether it is possible to continue using NovaRing. Disorders of the blood circulation. and arterial thrombosis, as well as related complications, sometimes fatal. The use of any CPC increases the risk of venous thrombosis Mboli (VTE) compared with the risk of VTE in patients not using the PDA. The greatest risk of developing VTE is observed in the first year of PDA use. Data from a large, prospective cohort study of the safety of various PDAs suggest that the greatest increase in risk, compared with the risk level in women who do not use PDA, is observed in the first 6 months after the start of PDA use or resumption of their use after a break (4 weeks or more) .In non-pregnant women who do not use oral contraceptives, the risk of developing VTE is from 1 to 5 cases per 10,000 women-years (WL). In women using oral contraceptives, the risk of developing VTE is from 3 to 9 cases per 10,000 LL. However, the risk rises to a lesser extent than during pregnancy, when it is 5–20 cases per 10,000 WL (data on pregnancy is based on the actual duration of pregnancy in standard studies; when calculated for 9 months of pregnancy, the risk ranges from 7 to 27 cases per 10,000 zhl). In women in the postpartum period, the risk of developing VTE is from 40 to 65 cases per 10,000 GF. VTE leads to a fatal outcome in 1-2% of cases. According to the results of studies, an increased risk of developing VTE in women using NovaRing is similar to that in women using PDAs (the adjusted risk ratio is presented in the table below). In a large prospective observational study TASC (Transatlantic active study of the safety of the use of the drug Novairing; for the cardiovascular system), an assessment of the risk of developing VTE in women who began to use Novairing was conducted; or PDAs that have switched to NovaRing; or PDA with other contraceptives or resumed use of the drug Novara; or PDA, in the typical user population. Women were monitored for 24-48 months. The results showed a similar level of risk for the development of VTE in women who use Noving; (a frequency of 8.3 cases per 10,000 GF), and for women using PDAs (a frequency of 9.2 cases per 10,000 GHL). For women who use PDAs, other than those containing desogestrel, gestodene, and drospirenone, the incidence of VTE was 8.5 cases per 10,000 JL. A retrospective cohort study initiated by the FDA showed that the incidence of VTE in women who started using NovarRing is 11.4 cases per 10,000 WL, while women who started using PDAs containing levonorgestrel, the incidence of VTE is 9.2 cases per 10,000 W. Risk assessment (risk ratio) of VTE in women who use NovingRing; compared with the risk of developing WTE among women, KPK Epidemiological research, population Drug (s) comparison Risk ratio (RR) (95% CI) TASC (Dinger, 2012) Women who have started using the drug (including again after a break) and have switched from other contraceptives.All available PDAs throughout the study1 OR2: 0.8 (0.5-1.5) Available PDAs, except those containing desogestrel, gestodene, drospirenone OP2: 0.9 (0.4-2.0) FDA-initiated study (Sydney, 2011) Women who started using combined hormonal contraceptives ) for the first time during the study period. PDAs available during the study period3 OP4: 1.09 (0.55-2.16) Levonorgestrel / 0.03 mg ethinyl estradiol OP4: 0.96 (0.47-1.95) 1 Incl. low-dose PDA containing the following progestogens: chlormadinone acetate, cyproterone acetate, desogestrel, dienogest, drospirenone, ethynodiol diacetate, gestodene, levonorgestrel, norethindrone, norgestimate