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 32-year-old woman comes to the hospital with vaginal spotting.  Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal.  Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL.  Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus.

Patient description (patient's own words): I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule.

Does the patient match the trial criteria? Contradiction