Buy Femoden dragee 21 pcs
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Gestodene, Ethinyl Estradiol

Bayer Pharma AG
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2019-09-19
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Clinical Pharmacology

Pharmacodynamics
Femoden - low-dose monophasic oral combination estrogen-progestin contraceptive drug.
The contraceptive effect of Femodene is carried out through complementary mechanisms, the most important of which are the suppression of ovulation and changes in the properties of the cervical secretion, as a result of which it becomes impermeable to spermatozoa.
In women taking combined oral contraceptives, the menstrual cycle becomes more regular, painful menstruation is less common, the intensity of bleeding decreases, resulting in a reduced risk of iron deficiency anemia. In addition, there is evidence that the risk of developing endometrial cancer and ovarian cancer is reduced.

Pharmacokinetics
Gestoden
Absorption. After ingestion, gestodene is rapidly and completely absorbed, its maximum concentration in serum, equal to 3.5 ng / ml, is reached in approximately 1 hour. Bioavailability is approximately 99%.
Distribution. Gestodene binds to serum albumin and sex-derived steroid steroids (GLSS). In free form is only about 1.3% of the total serum concentration; about 69% are specifically associated with SHGPS. Induction of ethinyl estradiol synthesis of GSPS affects the binding of gestodene with whey protein.
Metabolism. Gestodene is almost completely metabolized. Serum clearance is approximately 0.8 ml / min / kg.
Removal. The content of gestodene in serum undergoes a two-phase reduction. The elimination half-life in the terminal phase is about 12 hours. In unchanged form, gestodene is not excreted, but only in the form of metabolites, which are excreted in urine and bile in a ratio of about 6: 4 with a half-life of about 24 hours.
Equilibrium concentration. The GSPG serum level affects the pharmacokinetics of gestodene. As a result of the daily intake of the drug, the level of the substance in the serum increases about 4 times during the second half of the treatment cycle.

Ethinyl Estradiol
Absorption. After ingestion, ethinyl estradiol is rapidly and completely absorbed. The maximum serum concentration of approximately 65 pg / ml is reached in 1-2 hours. During suction and the first passage through the liver, ethinyl estradiol is metabolized, with the result that its bioavailability by ingestion is on average about 45%.
Distribution. Ethinyl estradiol is almost completely (approximately 98%), although not specific, bound by albumin. Ethinyl estradiol induces the synthesis of SHBG. The apparent volume of distribution of ethinyl estradiol is 2.8-8.6 l / kg.
Metabolism. Ethinyl estradiol is subjected to presystemic conjugation, both in the mucous membrane of the small intestine and in the liver. The main metabolic pathway is aromatic hydroxylation. The rate of clearance from blood plasma is 2.3-7 ml / min / kg.
Removal. The decrease in the concentration of ethinyl estradiol in the blood serum is biphasic; the first phase is characterized by a half-life of about 1 hour, the second - 10-20 hours. Unchanged from the body is not displayed. Ethinyl estradiol metabolites are excreted in urine and bile in a ratio of 4: 6 with a half-life of about 24 hours.
Equilibrium concentration. Equilibrium concentration is reached in approximately one week.

Indications

Contraception.

Composition

Each dragee contains:
Active substance: 0.075 mg of gestodene and 0.03 mg of ethinyl estradiol.
Excipients: lactose monohydrate, corn starch, povidone 25000, sodium calcium edetate, magnesium stearate, sucrose, povidone 700000, polyethylene glycol (macrogol) 6000, calcium carbonate, talc, montano-glycolic wax.

Gestodene, Ethinyl Estradiol is marketed under different brands and generic names, and comes in different dosage forms:

Brand nameManufacturerCountryDosage form
Femoden Bayer Pharma AG Germany dragee
Logest Bayer Pharma AG Germany dragee
Gestarelle® Haupt Pharma Münster GmbH Czech pills
Lindynette 30 Gedeon Richter Hungary pills
Lindynette 20 Gedeon Richter Hungary pills

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Gestodene, Ethinyl Estradiol

Dosage and Administration

Drops should be taken orally in the order indicated on the packaging, every day at about the same time, with a small amount of water. Take one dragee per day continuously for 21 days. Receiving the next pack begins after a 7-day break in taking the dragee, during which withdrawal bleeding usually occurs. Bleeding, as a rule, begins 2-3 days after taking the last dragee and may not end before the start of taking a new package.

How to start taking Femodin

  • In the absence of taking any hormonal contraceptives in the previous month.

Reception Femodena begins on the first day of the menstrual cycle (ie, on the first day of menstrual bleeding). It is allowed to start taking on the 2-5 day of the menstrual cycle, but in this case it is recommended to additionally use the barrier method of contraception during the first 7 days of taking pills from the first package.

  • When switching from other combined oral contraceptives.

It is preferable to start taking Femoden the next day after taking the last active dragee from the previous package, but in no case later than the next day after the usual 7-day break (for drugs containing 21 dragees) or after taking the last inactive dragee (for drugs containing 28 pills in the package).

  • When switching from contraceptives containing only gestagens (“mini-pili”, injection forms, implant), or from a gestagen-releasing intrauterine contraceptive (Mirena).

A woman can switch from a mini-drank to Femoden any day (without a break), from an implant or an intrauterine contraceptive with a progestogen — on the day of its removal, from an injection form — from the day when the next injection should be made. In all cases, you must use an additional barrier method of contraception during the first 7 days of taking pills.

  • After abortion in the first trimester of pregnancy.

A woman can start taking the drug immediately. Subject to this condition, the woman does not need additional contraceptive protection.

  • After childbirth or abortion in the second trimester of pregnancy.

It is recommended to start taking the drug on the 21-28 day after birth or abortion in the second trimester of pregnancy. If reception is started later, it is necessary to use an additional barrier method of contraception during the first 7 days of taking pills. However, if a woman has already lived sexually, before the start of Femodena, pregnancy should be excluded or it is necessary to wait for the first menstruation.
Reception of the missed dragees
If the delay in taking the drug was less than 12 hours, contraceptive protection is not reduced. A woman should take dragee as soon as possible, the following is taken at the usual time.
If the delay in taking the dragee is more than 12 hours, contraceptive protection can be reduced. In this case, you can follow the following two basic rules:

  • The drug should never be interrupted for more than 7 days.
  • 7 days of continuous pills are required to achieve adequate suppression of the hypothalamic-pituitary-ovarian regulation.

Accordingly, the following tips can be given if a delay in taking a dragee is more than 12 hours (the interval from the moment of taking the last dragee is more than 36 hours):

  • The first week of taking the drug

A woman should take the last missed dragee as soon as possible, as soon as she remembers (even if it means taking two dragees at the same time). The following pills are taken at the usual time. Additionally, a barrier method of contraception (for example, a condom) should be used within the next 7 days. If sexual intercourse took place during the week before skipping the dragees, it is necessary to consider the probability of pregnancy.The more drops are missed, and the closer they are to a break in taking active substances, the greater the likelihood of pregnancy.

  • Second week of taking the drug

A woman should take the last missed dragee as soon as possible, as soon as she remembers (even if it means taking two dragees at the same time). The following pills are taken at the usual time.
Provided that the woman took the pills correctly for 7 days preceding the first missed pills, there is no need to use additional contraceptive measures. Otherwise, as well as when skipping two or more dragees, it is necessary to additionally use barrier methods of contraception (for example, a condom) for 7 days.

  • Third week of taking the drug

The risk of reducing the reliability of contraception is inevitable due to the upcoming break in the reception of pills.
A woman should strictly adhere to one of the following two options. Moreover, if in the 7 days preceding the first missed pills, all the pills were taken correctly, there is no need to use additional contraceptive methods.
1. A woman should take the last missed dragee as soon as possible, as soon as she remembers (even if it means taking two dragees at the same time). The following dragees are taken at the usual time, until the dragees from the current package run out. The following packaging should begin immediately. Withdrawal bleeding is unlikely until the second pack ends, but there may be spotting and breakthrough bleeding while taking pills.
2. A woman may also interrupt the taking of pills from the current package. Then she should take a break for 7 days, including the day of skipping the dragees, and then start taking new packaging.
If a woman misses pills, and then during a break in taking pills, she has no withdrawal bleeding, it is necessary to exclude pregnancy.
Recommendations in case of vomiting and diarrhea
If a woman has vomiting or diarrhea within up to 4 hours after taking active dragees, absorption may not be complete and additional contraceptive measures should be taken. In these cases, you should focus on the recommendations when skipping dragees.
Change the day of the beginning of the menstrual cycle
In order to delay the onset of menstruation, a woman should continue to receive drops from the new Femoden package immediately after all the drops are taken from the previous one, without interruption in reception. Drops from this new packaging can be taken as long as the woman wants (until the packaging is over). While taking the drug from the second package, a woman may have spotting or breakthrough uterine bleeding. Resume taking Femodena from the new pack should be after the usual 7-day break.
In order to postpone the start of menstruation to another day of the week, a woman should be advised to speed up the next break in taking pills for as many days as she wants. The shorter the interval, the higher the risk that she will not have withdrawal bleeding, and in the future, there will be spotting and breakthrough bleeding while taking the second package (just as if she would like to delay the onset of menstruation).

Adverse reactions

When taking combined oral contraceptives, irregular bleeding (spotting or breakthrough bleeding) may occur, especially during the first months of use.
Other adverse effects have been observed in women on the background of combined oral contraceptive use.

Organ system Often
 (>1/100) 
Infrequently
(> 1/1000 and Rarely
 (
Organ of vision     contact lens intolerance (unpleasant sensations when wearing them)
Gastrointestinal tract nausea, abdominal pain vomiting, diarrhea  
Immune system     allergic reactions
Common symptoms weight gain   weight loss
Metabolism   fluid retention  
Nervous system headache migraine  
Mental disorders mood drop, mood swings decreased libido increase libido
Reproductive system and mammary glands mammary pain, breast engorgement breast hypertrophy vaginal discharge, breast discharge
Leather and subcutaneous tissue   rash, urticaria erythema nodosum, erythema multiforme

As with other combined oral contraceptives, in rare cases thrombosis and thromboembolism may occur.

Femoden should not be applied in the presence of any of the conditions listed below. If any of these conditions develop for the first time while receiving, the drug should be immediately canceled.

  • Thrombosis (venous and arterial) and thromboembolism at present or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders).
  • The states preceding thrombosis (including transient ischemic attacks, angina pectoris) are currently or in history.
  • Migraine with focal neurological symptoms now or in history
  • Diabetes with vascular complications.
  • Multiple or severe risk factors for venous or arterial thrombosis, including valvular heart disease, cardiac arrhythmias, vascular diseases of the brain or coronary arteries; uncontrolled arterial hypertension.
  • Pancreatitis with severe hypertriglyceridemia now or in history.
  • Liver failure and severe liver disease (until liver tests return to normal).
  • Liver tumors (benign or malignant) currently or in history.
  • Identified hormone-dependent malignant diseases (including genitals or mammary glands) or suspicion of them.
  • Vaginal bleeding of unknown origin.
  • Pregnancy or suspicion of her.
  • Lactation period.
  • Hypersensitivity to any of the components of the drug Femoden

Use with caution
If any of the conditions / risk factors listed below are present, then the potential risk and the expected benefits of using combined oral contraceptives in each individual case should be carefully weighed:

  • Risk factors for thrombosis and thromboembolism: smoking, thrombosis, myocardial infarction, or cerebrovascular accident at a young age in one of the closest relatives; obesity; dyslipoproteinemia (for example: arterial hypertension; migraine; valvular disease; cardiac arrhythmias, prolonged immobilization, serious surgical interventions, extensive trauma
  • Other diseases in which there may be violations of peripheral circulation: diabetes mellitus; systemic lupus erythematosus; hemolytic uremic syndrome; Crohn's disease and ulcerative colitis; sickle cell anemia; as well as phlebitis of the superficial veins
  • Hypertriglyceridemia
  • Liver diseases
  • Diseases that first arose or worsened during pregnancy or against the background of previous intake of sex hormones (for example, jaundice, cholestasis, gallbladder disease, otosclerosis with impairment of hearing, porphyria, herpes of pregnant women, Sydengham chorea)

Drug interactions

The interaction of oral contraceptives with other drugs can lead to breakthrough bleeding and / or a decrease in contraceptive reliability. The following types of interaction have been reported in the literature.
Impact on hepatic metabolism: The use of drugs that induce liver microsomal enzymes can lead to an increase in the clearance of sex hormones.Such drugs include: phenytoin, barbiturates, primidone, carbamazepine, rifampicin; There are also suggestions regarding oxcarbazepine, topiramate, felbamate, ritonavir and griseofulvin and preparations containing St. John's wort.
Influence on the enterohepatic circulation: According to individual studies, some antibiotics (for example, penicillins and tetracycline) can reduce the intestinal hepatic circulation of estrogen, thereby lowering the concentration of ethinyl estradiol.
During the taking of drugs that affect microsomal enzymes, and within 28 days after their withdrawal, the barrier method of contraception should be additionally used.
When taking antibiotics (such as ampicillins and tetracyclines) and for 7 days after their cancellation, you should additionally use a barrier method of contraception. If the period of use of the barrier protection method ends later than the pills in the package, you need to proceed to the next package of Femoden without the usual interruption in the reception of the pills. Oral combined contraceptives can affect the metabolism of other drugs (including cyclosporine), which leads to a change in their concentration in plasma and tissues.

Pregnancy and Lactation

Femoden is not prescribed during pregnancy and during breastfeeding.
If pregnancy is detected while taking the drug Femoden, the drug should be immediately canceled. However, extensive epidemiological studies have not revealed any increased risk of developmental defects in children born to women who received sex hormones before pregnancy or teratogenic effects, when sex hormones were taken carelessly in the early stages of pregnancy.
Reception of the combined oral contraceptives can reduce the amount of breast milk and change its composition, therefore, as a rule, their use is not recommended during lactation. A small amount of sex steroids and / or their metabolites can be excreted with milk, however, there is no evidence of their negative impact on the health of the newborn.

Special instructions

If any of the conditions / risk factors listed below are present, then the potential risk and the expected benefits of using combined oral contraceptives in each individual case should be carefully weighed in and discussed with the woman before she decides to start taking the drug. In the event of a worsening, aggravation, or first manifestation of any of these conditions or risk factors, the woman should consult with her physician, who may decide to discontinue the drug.

  • Diseases of the cardiovascular system

There is evidence of an increase in the incidence of venous and arterial thrombosis and thromboembolism (such as deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke) with combined oral contraceptives.
The risk of venous thromboembolism (VTE) is maximum in the first year of taking such drugs. The approximate incidence of VTE among women taking low-dose oral contraceptives (

The risk of thrombosis (venous and / or arterial) and thromboembolism increases:
- with age;
- in smokers (with an increase in the number of cigarettes or an increase in age, the risk further increases, especially in women over 35 years old);
in the presence of:
- family history (i.e., venous or arterial thromboembolism, ever with close relatives or parents at a relatively young age); in case of hereditary predisposition, the woman should be examined by an appropriate specialist to decide on the possibility of taking combined oral contraceptives;
- obesity (body mass index of more than 30 kg / m2);
- dyslipoproteinemia;
- arterial hypertension;
- migraine;
- valvular heart disease;
- atrial fibrillation;
- prolonged immobilization, serious surgery, any surgery on the legs or an extensive injury. In these situations, it is advisable to stop using the combined oral contraceptives (in the case of the planned operation, at least four weeks before it) and not to resume reception within two weeks after the end of immobilization.

The question of the possible role of varicose veins and superficial thrombophlebitis in the development of venous thromboembolism remains controversial. You should consider the increased risk of thromboembolism in the postpartum period.
Peripheral circulatory disorders can also occur in diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) and sickle cell anemia.
An increase in the frequency and severity of migraine during the use of combined oral contraceptives (which may precede cerebrovascular impairment) may be grounds for immediate discontinuation of these drugs.

  • Tumors

The most significant risk factor for cervical cancer is persistent papilloma viral infection. There are reports of some increase in the risk of cervical cancer with prolonged use of combined oral contraceptives. Connection with the reception of combined oral contraceptives is not proven. There are contradictions regarding the extent to which these findings are associated with screening for cervical pathology or with features of sexual behavior (more rare use of barrier methods of contraception).

It has also been found that there is a slightly increased relative risk of developing breast cancer diagnosed in women who used combined oral contraceptives (relative risk 1.24). The increased risk gradually disappears within 10 years after discontinuation of these drugs. His connection with the reception of combined oral contraceptives has not been proven. The observed increase in risk may also be due to an earlier diagnosis of breast cancer in women using combined oral contraceptives. In women who have ever used combined oral contraceptives, earlier stages of breast cancer are detected than in women who have never used them.
In rare cases, on the background of the use of combined oral contraceptives, the development of liver tumors was observed, which in some cases led to life-threatening intra-abdominal bleeding. In the event of severe abdominal pain, enlargement of the liver or signs of intra-abdominal bleeding, this should be considered when conducting a differential diagnosis.

  • Other states

Women with hypertriglyceridemia (or in the presence of this condition in the family history) may increase the risk of developing pancreatitis while taking combined oral contraceptives.
Although a slight increase in blood pressure has been reported in many women taking combined oral contraceptives, clinically significant increases have been rare. However, if a persistent, clinically significant increase in blood pressure develops while taking combined oral contraceptives, these drugs should be canceled and treatment of hypertension should begin. Reception of the combined oral contraceptives can be continued if normal blood pressure values ​​are achieved with the help of antihypertensive therapy.

The following conditions have been reported to develop or worsen both during pregnancy and when taking combined oral contraceptives, but their relationship with taking combined oral contraceptives has not been proven: jaundice and / or itching associated with cholestasis; the formation of gallstones; porphyria; systemic lupus erythematosus; hemolytic uremic syndrome; chorea; herpes pregnant; hearing loss associated with otosclerosis. Also described are cases of Crohn's disease and ulcerative colitis associated with the use of combined oral contraceptives.

Acute or chronic liver dysfunction may require discontinuation of combined oral contraceptives until liver function returns to normal. Recurrent cholestatic jaundice, which develops for the first time during pregnancy or a previous intake of sex hormones, requires the discontinuation of combined oral contraceptives.
Although combined oral contraceptives may affect insulin resistance and glucose tolerance, there is no need to change the therapeutic regimen in patients with diabetes who use low-dose combined oral contraceptives (Sometimes chloasma can develop, especially in women with a history of chloasma pregnant. Women with a tendency to chloasma while taking combined oral contraceptives should avoid prolonged exposure to the sun and exposure to trafioletovogo radiation.

Laboratory tests
Acceptance of combined oral contraceptives can affect the results of some laboratory tests, including indicators of liver, kidney, thyroid, adrenal glands, plasma transport protein levels, carbohydrate metabolism, coagulation and fibrinolysis parameters. Changes usually do not go beyond the normal range.

Effect on the menstrual cycle
Irregular bleeding (spotting or breakthrough bleeding) may occur during combined oral contraceptives, especially during the first months of use. Therefore, any irregular bleeding should be evaluated only after a period of adaptation of approximately three cycles.
If irregular bleeding recurs or develops after previous regular cycles, a thorough examination should be performed to rule out malignant tumors or pregnancy.
Some women may not develop withdrawal bleeding during a break in the dragee taking. If combined oral contraceptives were taken as directed, it is unlikely that the woman is pregnant. However, if previously combined oral contraceptives were taken irregularly or, if there are no two withdrawal bleeding in a row, pregnancy should be ruled out before continuing to take the drug.

Medical examinations
Before starting or resuming use of Femoden, you should familiarize yourself with the history of life, family history of a woman, conduct a thorough general medical (including measurement of blood pressure, heart rate, determination of body mass index) and gynecological examination (including breast examination and cytological examination of cervical mucus) pregnancy. The amount of additional research and the frequency of control examinations is determined individually.
Usually control tests should be carried out at least 1 time per year.
A woman should be warned that femoden-type drugs do not protect against HIV infection (AIDS) and other sexually transmitted diseases!
Influence on the ability to drive and technology. Not found.

Overdosage

No serious violations in overdose were reported. Symptoms that may occur with an overdose: nausea, vomiting, spotting, or metrorrhagia.
There is no specific antidote; symptomatic treatment should be carried out.

  • Brand name: Femoden
  • Active ingredient: Gestoden, Ethinyl Estradiol
  • Dosage form: dragee
  • Manufacturer: Bayer Pharma AG
  • Country of Origin: Germany

Studies and clinical trials of Gestodene, Ethinyl Estradiol (Click to expand)

  1. GenToS: Use of Orthologous Gene Information to Prioritize Signals from Human GWAS
  2. Oral contraceptives containing ethinyl estradiol and gestodene markedly increase plasma concentrations and effects of tizanidine by inhibiting cytochrome P450 1A2
  3. Safety and efficacy of a combined oral contraceptive: Gestodene 75 μg plus ethinyl estradiol 30 μg in Mexican women
  4. Comparative study on the acceptability of two modern monophasic oral contraceptive preparations: 30 μg ethinyl estradiol combined with 150 μg desogestrel or 75 μg gestodene
  5. Six-month carbohydrate metabolism studies in women using oral contraceptives containing gestodene and ethinyl estradiol
  6. Triphasic combination of ethinyl estradiol and gestodene long-term clinical trial
  7. Influence of gestodene and desogestrel as components of low-dose oral contraceptives on the pharmacokinetics of ethinyl estradiol (EE2), on serum CBG and on urinary cortisol and 6β-hydroxycortisol
  8. Clinical comparison of monophasic oral contraceptive preparations of gestodene/ ethinyl estradiol and desogestrel/ethinyl estradiol
  9. Carbohydrate metabolism studies after one year of using an oral contraceptive containing gestodene and ethinyl estradiol
  10. Clinical and metabolic aspects of the continuous use of a contraceptive association of ethinyl estradiol (30 μg) and gestodene (75 μg)
  11. Double-blind, multicenter comparison of efficacy, cycle control, and tolerability of a 23-day versus a 21-day low-dose oral contraceptive regimen containing 20 μg ethinyl estradiol and 75 μg gestodene
  12. Open, multicenter comparison of efficacy, cycle control, and tolerability of a 23-day oral contraceptive regimen with 20 μg ethinyl estradiol and 75 μg gestodene and a 21-day regimen with 20 μg ethinyl estradiol and 150 μg desogestrel
  13. A double-blind comparative study of the effects of a 23-day oral contraceptive regimen with 20 μg ethinyl estradiol and 75 μg gestodene and a 21-day regimen with 30 μg ethinyl estradiol and 75 μg gestodene on hemostatic variables, lipids, and carbohydrate metabolism
  14. Effect of two oral contraceptives containing ethinyl estradiol and gestodene or norgestimate on different lipid and lipoprotein parameters
  15. Comparative studies of 30 μg ethinyl estradiol combined with gestodene and desogestrel on blood coagulation, fibrinolysis, and platelets
  16. Effect of 21-day and 24-day oral contraceptive regimens containing gestodene (60 μg) and ethinyl estradiol (15 μg) on ovarian activity
  17. Protein binding of active ingredients and comparison of serum ethinyl estradiol sex hormone-binding globulin, corticosteroid-binding globulin, and cortisol levels in women using a combination of gestodene/ ethinyl estradiol (Femovan) or a combination of desogestrel/ ethinyl estradiol (Marvelon) and single-dose ethinyl estradiol bioequivalence from both oral contraceptives
  18. Pharmacokinetics of gestodene and ethinyl estradiol after oral administration of a monophasic contraceptive
  19. Comparative studies of 30 μg ethinyl estradiol combined with gestodene and desogestrel on blood coagulation, fibrinolysis, and platelets
  20. Impact of body mass index on suppression of follicular development and ovulation using a transdermal patch containing 0.55-mg ethinyl estradiol/2.1-mg gestodene: a multicenter, open-label, uncontrolled study over three treatment cycles
  21. Simultaneous Determination of Gestodene and Ethinyl Estradiol in Contraceptive Formulations by RP‐HPLC
  22. Effect of a combined oral contraceptive containing 20 μg ethinyl estradiol and 75 μg gestodene on hemostatic parameters
  23. Pharmacokinetic drug–drug interaction between ethinyl estradiol and gestodene, administered as a transdermal fertility control patch, and two CYP3A4 inhibitors and a CYP3A4 substrate
  24. Effects of an ethinyl estradiol/gestodene transdermal contraceptive patch on the endometrium: a single-center, uncontrolled study
  25. Clinical trial of a monophasic estroprogestin oral formulation containing 20 μg ethinyl estradiol and 75 μg gestodene

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