Status:
COMPLETED
Evaluation of Ciclo 21® Effect (Levonorgestrel + Ethinyl Estradiol) Compared to Nordette®.
Lead Sponsor:
Azidus Brasil
Collaborating Sponsors:
União Química Farmacêutica Nacional S/A
Conditions:
Irregular Periods
Eligibility:
FEMALE
18-35 years
Phase:
PHASE3
Brief Summary
Assessment of the pharmacodynamic profile of the drug Ciclo 21 ®, marketed by União Química Farmacêutica Nacional S / A, compared to the drug Nordette ® Laboratory Wyeth Pharmaceutical Ltda. Through t...
Detailed Description
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 * Evaluatio...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT01480778
Start Date
July 1 2014
End Date
June 1 2015
Last Update
March 3 2016
Active Locations (1)
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1
LAL Clínica Pesquisa e Desenvolvimento Ltda
Valinhos, São Paulo, Brazil