Evaluation of Ciclo 21® Effect (Levonorgestrel + Ethinyl Estradiol) Compared to Nordette®.

secondary objective

• Evaluation of the safety aspects of medicines such as type, frequency and intensity of adverse events between groups during the 28 day trial.

exploratory objective

• Evaluation of the pharmacokinetics of the drug administered through the dosage of serum hormone levonorgestrel and ethinyl estradiol for 28 days.

Inclusion criteria

• Comply with all study procedures, sign, initial and date back, of their own free will, the IC;
• Women aged between 18 and 35 years, regardless of race and class;
• Make use of safe non-hormonal method of contraception such as tubal ligation, non-hormonal IUDs or condoms, or be hysterectomised or be vasectomized sexual partner;
• Examination of Beta-HCG negative;
• with regular menstrual cycles every 24 to 32 days, at least the last three months;
• present normal Pap test (current or during the past 02 years);
• Present or vaginal examination found that the changes do not interfere in the study;
• present levels of FSH, LH, estradiol and TT for the normal menstrual cycle, as well as normal transvaginal sonographic reports.

Exclusion criteria

• Provide a contraindication to the use of steroids;
• Use regular or prediction of drugs that interfere with the metabolism of the investigational products, such as antibiotics, anticonvulsants, anticoagulants and hypoglycemic drugs;
• smokers or have stopped smoking less than 12 months;
• Diabetic;
• Toxic-dependent;
• BMI <18 and> 25;
• have made use of topical or systemic sex hormone for at least two months before the start of the study;
• Background and personal or family history of thrombosis or bleeding disorders or vascular disorders or cardiovascular disease;
• Laboratory tests, gynecological ultrasound or changed, the medical criteria;
• Individuals with allergies or rheumatic diseases for which is indicated the use of cortico-steroid medication;
• carry any endocrine changes, especially pituitary and gonadal and / or who are advised to use hormones;
• with lesions or abnormalities suspected or confirmed in the gonads.
• personal or family history of breast cancer or other hormone-dependent breast pathology;
• with hypertension or diabetes mellitus (for drug interactions between the COC and hypoglycemic agents and antihypertensives);

a) History of nausea with oral use of COCs; p) Any condition that may interfere with the discretion of the investigator in the study data as well as being the measurement of the study be deleterious to the patient.