Clinical trial: Evaluation of Ciclo 21® Effect (Levonorgestrel + Ethinyl Estradiol) Compared to Nordette®. (NCT01480778)

Eligibility criteria:
Inclusion Criteria:

          1. Comply with all study procedures, sign, initial and date back, of their own free will,
             the IC;

          2. Women aged between 18 and 35 years, regardless of race and class;

          3. 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;

          4. Examination of Beta-HCG negative;

          5. with regular menstrual cycles every 24 to 32 days, at least the last three months;

          6. present normal Pap test (current or during the past 02 years);

          7. Present or vaginal examination found that the changes do not interfere in the study;

          8. present levels of FSH, LH, estradiol and TT for the normal menstrual cycle, as well as
             normal transvaginal sonographic reports.

        Exclusion Criteria:

          1. Provide a contraindication to the use of steroids;

          2. Use regular or prediction of drugs that interfere with the metabolism of the
             investigational products, such as antibiotics, anticonvulsants, anticoagulants and
             hypoglycemic drugs;

          3. smokers or have stopped smoking less than 12 months;

          4. Diabetic;

          5. Toxic-dependent;

          6. BMI <18 and> 25;

          7. have made use of topical or systemic sex hormone for at least two months before the
             start of the study;

          8. Background and personal or family history of thrombosis or bleeding disorders or
             vascular disorders or cardiovascular disease;

          9. Laboratory tests, gynecological ultrasound or changed, the medical criteria;

         10. Individuals with allergies or rheumatic diseases for which is indicated the use of
             cortico-steroid medication;

         11. carry any endocrine changes, especially pituitary and gonadal and / or who are advised
             to use hormones;

         12. with lesions or abnormalities suspected or confirmed in the gonads.

         13. personal or family history of breast cancer or other hormone-dependent breast
             pathology;

         14. 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.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 35 Years

Patient description (medical language): A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles.  The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days.  She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal.  On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis.

Patient description (patient's own words): I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis.

Does the patient match the trial criteria? Contradiction