LUCILLE ® - Ethinyl estradiol + Desogestrel

LUCILLE ® is a drug based on ethinyl estradiol + desogestrel

THERAPEUTIC GROUP: Three-phase systemic hormonal contraceptives based on progestins and estrogens.

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Indications LUCILLE ® - Contraceptive Pill

LUCILLE ® is used as an oral contraceptive.

Action mechanism LUCILLE ® - Contraceptive Pill

LUCILLE ®, as well as all the other estrogen progestagens present in the market, owes its anti-conventional action to the biological effects of ethinylestradiol and desogestrel contained in it.

More precisely, this activity is carried out through:

The inhibition of follicular and ovarian maturation processes, therefore also of ovulation, mediated by the negative feedback induced by the two active principles at the hypothalamic and pituitary level, on the endogenous secretion of gonadotropins;
The change in chemical-physical properties of the cervical mucus and of the endometrium, such as to make sperm ascent more difficult in the female genital tract and to prevent the endometrial implantation of the embryo.

The use of triphasic oral contraceptives has also proved effective in reducing the frequency of intermenstrual spotting and regularizing the extent, duration and intensity of the cycle.

Studies carried out and clinical efficacy

1. THREE-PHASE ORAL CONTRACEPTIVES AND OVARIAN FUNCTIONALITY

Work demonstrating that despite the use of triphasic oral contraceptives present an efficacy comparable to that of monobasic contraceptives, the overall ovarian activity is slightly increased. These effects are more evident in low progestin-based contraceptives.

2. EXTROPROGESTINES DURING THE MENOPAUSE

Despite the hormone replacement therapy based on progestin-like estrus like LUCILLE ® was useful during the menopausal transition phase in regularizing the menstrual cycle and preventing vaginal dryness, nothing could be done against incontinence problems.

3. THE EFFECTS OF ORAL CONTRACEPTIVES ON THE CHEMICAL-PHYSICAL PROPERTIES OF LIPOPROTEINS

Molecular study that demonstrates how the increased risk of embolic and coronary artery thrombus events linked to estrogen progestogen intake may be associated with the composition change of the apolipoproteins contained in lipoproteins, with a significant reduction in size, therefore with an increased risk of infiltration in the arterial wall.

Method of use and dosage

LUCILLE ®

6 yellow coated tablets of 35 mcg of ethinyl estradiol and 50 of desogestrel;

5 red coated tablets of 30 mcg of ethinyl estradiol and 100 mcg of desogestrel;

10 white coated tablets of 30 mcg of ethinyl estradiol and 150 mcg of desogestrel;

taking LUCILLE ® follows the classic dosage schedules, with 21-day cycles interspersed with 7-day long suspension periods, in which suspension bleeding similar to menstruation should take place.

The intake of this tablet, which should take place every day at the same time, is made easier by the presence of a calendar on the blister, which minimizes doubts and problems related to the different dosages and methods of intake.

Changes in the normal dosing schedule, especially in the initial phase of treatment, may be necessary in the event of a recent pregnancy or abortion, previous use of oral contraceptives or in case of forgetfulness.

In the above cases it is necessary to strictly follow the instructions of your doctor.

Warnings LUCILLE ® - Contraceptive Pill

The intake of LUCILLE ® as well as that of other oral contraceptives, must necessarily be preceded by a careful medical-gynecological check-up, useful for ascertaining the absence of conditions capable of compromising the patient's state of health.

In light of the various epidemiological studies in which an increase in cardiovascular risk was observed associated with arterial and venous thrombomebolic events, and an increase in neoplastic diseases, the presence of risk factors such as smoking; diabetes; overweight; hypertension; heart valve defects or some heart rhythm disorders; superficial phlebitis (venous inflammation), varicose veins; migraine; depression; epilepsy; high levels of cholesterol and triglycerides in the blood, present or past, even in close family members; breast lumps; previous, in next family members, of breast cancer; liver or gallbladder disease; Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease); systemic lupus erythematosus (pathology that affects the skin of the whole body); hemolytic-uremic syndrome (blood clotting disorder that causes renal failure); sickle cell disease; porphyria; chloasma, present or past (patches on the skin with yellowish-brown pigmentation, in particular on the face, should be taken seriously into consideration before undertaking LUCILLE ®

In the aforementioned cases, after carefully examining the cost / benefit ratio of hormone progestogen-based contraception, it would be useful to set periodic checks in order to monitor the patient's state of health, promptly reviving any pathological processes.

LUCILLE ® contains lactose so that its intake in patients with lactase enzyme deficiency, glucose / galactose malabsorption or lactose intolerance, could be associated with severe gastrointestinal disorders.

PREGNANCY AND BREASTFEEDING

Taking LUCILLE ® throughout pregnancy is contraindicated due to the absence of both indications of use and clinical trials able to characterize the safety profile of the drug on fetal health.

These contraindications also extend to the subsequent breastfeeding period given the ability of ethinyl estradiol and desogestrel to pass through the breast filter and concentrate in breast milk.

Interactions

The hepatic metabolism to which both desogestrel and ethinyl estradiol are subjected, determines a significant increase in the possible pharmacological interactions worthy of note.

More precisely, multiple inducers of citrochromial enzymes, such as primidone, phenytoin, barbiturates, carbamazepine, (used to treat epilepsy), rifampicin (used to treat tuberculosis), ampicillin, tetracyclines, la griseofulvin (antibiotics used for the treatment of infectious diseases), ritonavir, modafinil and sometimes St. John's wort (hypericum perforatum), capable of altering the functionality of cytochromial enzymes, could increase the metabolism of ethinyl estradiol and desogestrel, reducing thus the contraceptive efficacy of LUCILLE ®

In this case, therefore, it would be particularly advisable to consult your doctor, possibly considering taking a method of contraception.

Different interactions were also observed on some laboratory parameters, with significant variations in the plasma concentrations of markers of hepatic, thyroid, adrenal and renal function.

Contraindications LUCILLE ® - Contraceptive Pill

LUCILLE ® is contraindicated in case of current or previous venous thrombosis, stroke, hypertension, metabolic pathologies such as diabetes mellitus, hypertension and dyslipidemia, liver and kidney function changes, malignant pathologies, neuro-psychiatric disorders, motor disorders, undiagnosed gynecological disorders and in case of hypersensitivity to the active ingredient or to one of its excipients.

Undesirable effects - Side effects

Despite the use of innovative progestogens such as desogestrel and the formulation of low-dose tablets, the use of oral contraceptives such as LUCILLE ® is associated with side reactions from the different clinical course.

The most frequent side effects have been described: altered mood, headache, nausea and abdominal pain, increased breast tenderness and tenderness, weight gain, vomiting and diarrhea, headache and skin disorders.

Fortunately the cases of hypersensitivity, arterial and venous thromboembolic disorders, hypertension and coronary artery disease, biliary lithiasis, liver tumors and mammary carcinomas have been rarer.