"Proginova" when planning pregnancy: what is it prescribed for and when can it be taken

How to take Proginova when planning pregnancy?

Taking the drug "Proginova" is designed for 21 days. The first pill is taken in the first five days of the menstrual cycle or on any day if there is no menstrual cycle.

There are two regimens for taking the drug: cyclic and continuous.

Cyclic use of the drug "Proginova"

The drug is taken daily, one tablet for 21 days, after which a seven-day break is taken. On the eighth day, the next dosage cycle begins, again lasting 21 days.

Continuous use of the drug "Proginova"

The drug is taken for 21 days, and from the 22nd day, without a break, a new cycle of administration begins.

The drug regimen is selected by the woman’s attending physician.

Pregnancy often occurs after the first course of treatment with the drug.

The drug "Proginova" cannot be taken4:

during pregnancy more than eight weeks;
during breastfeeding;
simultaneously with other estrogen-containing drugs, including contraceptives;
for vaginal bleeding;
for tumor neoplasms, diseases of the liver, gallbladder, pancreas, diabetes mellitus, lactase deficiency, tendency to thrombus formation.

Before prescribing the Proginova hormone, the doctor will conduct a full examination of the woman and decide whether this drug is suitable for her. If it cannot be used or is ineffective, the doctor will prescribe other hormonal medications that will help bring the long-awaited moment of conception closer and carry a healthy child.

Instructions for use CYCLO-PROGYNOVA

leiomyoma (uterine fibroids) or endometriosis;
history of thromboembolic disorders or risk factors for thromboembolic disorders;
risk factors for the formation of estrogen-dependent tumors, for example, stage 1 breast cancer;
hypertension;
liver diseases (for example, liver adenoma);
kidney diseases;
diabetes mellitus with or without vascular damage;
cholelithiasis;
migraine or headache (severe);
systemic lupus erythematosus (SLE);
history of endometrial hyperplasia;
epilepsy;
multiple sclerosis;
asthma;
otosclerosis;
itching;
chorea.

In case of development or exacerbation of any of the following diseases/risk factors, before starting or continuing HRT, it is recommended to conduct a repeated individual analysis of the benefit-risk ratio of the drug, taking into account the possible need to discontinue treatment.

When prescribing HRT to women who have several risk factors or increased severity of a particular risk factor, the possibility of increasing the synergistic effect of the prescribed treatment on the development of thrombosis should be taken into account. Such an increase in risk for the patient may exceed the total degree of risk factors. HRT should not be prescribed if the results of the benefit-risk assessment are negative.

Venous thromboembolism

A number of controlled randomized as well as epidemiological studies have revealed an increased relative risk of developing venous thromboembolism (VTE) during HRT, i.e. deep vein thrombosis or pulmonary embolism. Therefore, when prescribing HRT to women with risk factors for VTE, the risk-benefit ratio of treatment should be carefully weighed and discussed with the patient.

Risk factors for developing VTE include individual and family history (the presence of VTE in first-degree relatives at a relatively young age may indicate a genetic predisposition) and severe obesity. The risk of VTE also increases with age. The possible role of varicose veins in the development of VTE remains controversial.

The risk of developing VTE may temporarily increase with prolonged immobilization, after major elective or post-traumatic surgery, or severe trauma. The question of the advisability of temporarily stopping HRT should be decided depending on the nature of the circumstances and the duration of immobilization.

Arterial thromboembolism

Randomized controlled trials with long-term use of combined conjugated estrogens (CCE) and medroxyprogesterone acetate did not provide evidence of a beneficial effect on the cardiovascular system. In large-scale clinical trials of this compound, a possible increased risk of coronary disease was identified in the first year of use. An increased risk of stroke was also found. To date, no long-term randomized controlled trials have been conducted with other HRT drugs to identify beneficial effects on cardiovascular morbidity and mortality. It is therefore unknown whether this increased risk applies to HRT products containing other types of estrogens and progestogens.

Cardiovascular diseases

HRT should not be used to prevent cardiovascular disease. Data from randomized controlled trials do not show a cardiovascular benefit from long-term use of the tablets in combination with conjugated estrogens and medroxyprogesterone acetate (MPA). Two large-scale clinical studies (WHI and HERS:

heart study and estrogen/progestogen therapy) showed a possible increased risk of cardiovascular disease in the first year of using the pill, as well as a lack of overall health benefit.

A large clinical trial (WHI study) found, as a secondary outcome, that there was an increased risk of stroke in healthy women when taking the pill in combination with conjugated estrogens and MPA. In women who do not take HRT, the incidence of stroke that may occur within 5 years is estimated to be about 3 per 1000 women aged 50-59 years and 11 per 1000 women aged 60-69 years. It is estimated that for women taking conjugated estrogens and MPA for 5 years, the number of additional cases of stroke would be 0 to 3 cases (best estimate = 1 case) per 1000 women aged 50–59 years and 1 to 9 cases ( best estimate = 4 cases) per 1000 women aged 60-69 years who take the pill.

For other HRT products, there is only limited data from randomized controlled trials to assess the risk of cardiovascular disease and or stroke associated with HRT. Therefore, there is no data to conclude that the incidence of cardiovascular disease or stroke may change depending on the use of Cyclo-Progynov.

Cholelithiasis

It is known that estrogens increase the lithogenicity of bile. Some women are predisposed to developing gallstones during estrogen treatment.

Dementia

There is limited clinical trial data with CEE-containing products to suggest that hormonal therapy may increase the risk of eventual dementia when treated older. The risk may be reduced if HRT is started early in menopause, as has been observed in studies. It is not known whether this applies to other HRT medications.

Tumors

Endometrial cancer

The risk of endometrial hyperplasia and cancer increases in women who receive estrogens for a long time. Adding progestogen for at least 12 days per cycle in women without a hysterectomy significantly reduces the risk of these diseases.

During the first months of treatment, bleeding and spotting may occur. If such bleeding appears some time after the start of treatment or persists after cessation of treatment, then an investigation of its etiology should be carried out, and an endometrial biopsy should be performed to exclude malignancy.

Mammary cancer

The Women's Health Initiative (WHI) controlled clinical trial, the Million Women Study (MWS), and epidemiological studies indicate an increased risk of breast cancer in women taking estrogens, estrogens plus progestogens, or tibolone as HRT for several years. For all HRT products, excess risk becomes apparent during the first years of use of the drug and increases with duration of use, but returns to baseline values within approximately 5 years after stopping treatment. According to the MWS, the risk of developing mammary cancer with conjugated equine estrogens or estradiol was greater when they were taken sequentially or continuously in combination with a progestogen. The type of progestogen taken does not matter in this case. These studies do not indicate a difference in risk between different routes of drug administration.

In the WHI study, continuous administration of conjugated equine estrogens and medroxyprogesterone acetate was associated with larger breast cancers as well as a higher incidence of lymph node metastases compared with placebo.

Estimates of the overall relative risk of breast cancer detection reported in more than 50 epidemiological studies ranged from 1 to 2 in most studies.

Estimates of the overall relative risk of developing breast cancer from more than 50 epidemiological studies ranged between 1 and 2 in most studies.

For the WHI (Women's Health Initiative), a relative risk estimate of 1.24 (95% CI:

from 1.01 to 1.54), after 5-6 years of continuous use of HRT (conjugated equine estrogens (CLE) + medroxyprogesterone acetate (MPA)) compared with placebo. This results in an increase of 8 cases of invasive breast cancer diagnosis per 10,000 women per year (33 cases among women not taking the drug compared to 41 cases among women taking combination HRT).

HRT, especially the estrogen-progestogen combination, increases the density of mammographic images, which may interfere with the detection of breast cancer.

Ovarian cancer

Long-term treatment with HRT (at least 5 to 10 years) with estrogen-only products in women who have had a hysterectomy is associated with an increased risk of developing ovarian cancer, according to some epidemiological studies. It is unclear whether the risk of ovarian cancer with long-term use of combined HRT is different from the risks associated with estrogen-only products.

Liver tumors

During the use of sex steroids, which include drugs for HRT, in rare cases benign, and even more rarely, malignant liver tumors were observed. In some cases, these tumors have resulted in life-threatening intra-abdominal bleeding. If there is pain in the upper abdomen, an enlarged liver, or signs of intra-abdominal bleeding, the differential diagnosis should take into account the possibility of a liver tumor.

Other states

Estrogens can affect fluid retention; Therefore, patients with impaired cardiac or renal function should be carefully monitored. Patients with end-stage renal failure should undergo regular follow-up examinations, because It should be assumed that the drug Cyclo-Proginova increases the level of circulating active substances in plasma.

Estrogens increase the concentration of thyroid globulin (TG), which leads to an increase in circulating thyroid hormones, which is reflected in the level of PBI (protein iodine), T4 level (determined by bars or radioimmunoassay), or T3 level (determined by radioimmunoassay). If T3 uptake decreases, this is reflected by an increase in GTG. The concentrations of free T3 and T4 remain unchanged. Serum concentrations of other proteins may also be altered, including corticosteroid binding globulin (CBG), sex hormone globulin (SHBG), resulting in increased corticosteroid and serum steroid levels, respectively. The concentrations of free hormones or biologically active hormones do not change. Other plasma proteins such as angiotensinogen/renin substrate, alpha-1 antitrypsin, ceruloplasmin may also be increased. The relationship between HRT and the development of clinically significant arterial hypertension has not been established. A slight increase in blood pressure has been described in women taking HRT; clinically significant increases are rare. However, in some cases, if persistent clinically significant arterial hypertension develops while taking HRT, discontinuation of HRT may be considered.

For mild liver dysfunction, including various forms of hyperbilirubinemia, such as Dubin-Johnson syndrome or Rotor syndrome, medical supervision is necessary, as well as periodic liver function tests. If liver function tests worsen, HRT should be discontinued.

Special monitoring is required for women with moderately elevated triglyceride levels. In such cases, the use of HRT may cause a further increase in the level of triglycerides in the blood, which increases the risk of acute pancreatitis.

Despite the fact that HRT can affect peripheral insulin resistance and glucose tolerance, there is usually no need to change the treatment regimen of patients with diabetes when undergoing HRT. However, women with diabetes should be monitored when undergoing HRT.

Some patients under the influence of HRT may develop undesirable manifestations of estrogen stimulation, such as abnormal uterine bleeding. Frequent or persistent pathological uterine bleeding during treatment is an indication for endometrial examination.

If treatment for irregular menstrual cycles does not produce results, an examination should be performed to exclude an organic disease.

Under the influence of estrogens, fibrous tumors of the uterus (fibroids) can increase in size. In this case, treatment should be stopped.

It is recommended to discontinue treatment if endometriosis relapses during HRT.

If a prolactinoma is detected in a patient, the patient should be under close medical supervision (including periodic assessment of prolactin concentrations).

In some cases, chloasma may occur, especially in women with a history of chloasma during pregnancy. During HRT, women prone to chloasma should avoid exposure to the sun or ultraviolet radiation.

It has been found that the following conditions may occur or worsen during HRT. Although it cannot be said with certainty that these changes are related to HRT, patients undergoing HRT who are diagnosed with the following conditions should be closely monitored:

epilepsy, benign breast tumor, asthma, migraine, porphyria, ostosclerosis, systemic lupus erythematosus, chorea minor.

In women with hereditary forms of angioedema, exogenous estrogens may cause or worsen symptoms of angioedema.

Effect on clinical and chemical parameters

Estrogens increase thyroxine-binding globulin (TBG) concentrations, thereby increasing total circulating thyroid hormone levels as measured by protein-bound iodine (PBI), T4 levels (by column separation or radioimmunoassay), and T3 levels (by radioimmunoassay). T3 resin absorption decreases, which is reflected in the TSH level. The concentrations of free T4 and T3 do not change. Serum levels of other binding proteins, such as corticoid binding globulin (CBG) and sex hormone binding globulin (SHBG), may be elevated, resulting in increased levels of circulating corticoids or sex hormones. Free or biologically active hormone concentrations remain unchanged. Levels of other plasma proteins (angiotensinogen/renin substrate, β1-antitrypsin, ceruloplasmin) may be increased.

Medical examinations

Before starting or resuming HRT, you should review the patient's medical history in detail and conduct a physical and gynecological examination. The frequency and nature of such examinations should be based on existing standards of medical practice, taking into account the individual characteristics of each patient, and should include measurement of blood pressure, assessment of the condition of the mammary glands, abdominal and pelvic organs, including cytological examination of the cervical epithelium.

Situations requiring monitoring

Patients should be monitored regularly if any of the following situations exist, or if there is a current or history of disease, or if the woman's condition worsens during pregnancy or hormonal treatment. This also applies if one of the following situations or diseases occurs or worsens during current hormone replacement therapy with Cyclo-Proginova:

leiomyoma (uterine fibroids) or endometriosis;
history of thromboembolism or relevant risk factors;
risk factors for estrogen-dependent tumors, for example, the occurrence of breast cancer in first-degree relatives;
hypertension;
liver diseases (for example, hepatoma);
diabetes mellitus with or without vascular damage;
cholelithiasis;
migraines or (severe) headaches;
systemic lupus erythematosus (SLE);
history of endometrial hyperplasia;
epilepsy;
asthma;
otosclerosis;
fibrocystic mastopathy;
congenital severe disorders of fat metabolism;
severe obesity;
sickle cell anemia.

Impact on the ability to drive vehicles and machinery

not found.