Clinical Trial With Combination of Dienogest/Ethytnilestradiol and Drosperidona/Ethyniestradiol

Launched by EUROFARMA LABORATORIOS S.A. · Mar 16, 2012

Keywords

ClinConnect Summary

No description provided

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Sign, initial and date the informed consent form;
• • Female patients, with child bearing potential, aged 18 to 35 years;
• • Have indication to receive progesterone and estrogen-based low oral hormone treatment for at least 7 cycles (approximately 7 months) for birth control;
• • Be able to comply with the study protocol;
• • Show normal result in cervical-vaginal cytology conducted up to 3 months before study enrollment or be willing to repeat the screening visit test, which result must also be normal;
• • Be willing to use one of the study drugs
• Exclusion Criteria:
• • Is pregnant or breastfeeding, suspecting to be or planning to get pregnant;
• • Patients currently using oral contraceptives with drospirenone 3 mg/ ethynilestradiol 30 mcg or dianogest 2 mg/ ethynilestradiol 30 mcg.
• • Have history of gynecologic surgery such as hysterectomy, total oophorectomy or tubal ligation;
• • Smoke over 10 cigarettes a day;
• • Have any severe comorbidities (at the investigator's criteria), including bowel inflammatory disease
• * Have hypertension, showing at least one of the following conditions:
• • Systolic pressure \>140 mm Hg or diastolic pressure \>90 mm Hg in sitting position;
• • Current use of pharmacological treatment for hypertension;
• • Show history or currently have venous or arterial thromboembolism;
• • History of breast or genital cancer;
• • Have obesity (BMI \>30 kg/m2);
• • Have liver disease or changed lab values;
• • Currently have dysplasia or malignancy in cervical-vaginal cytology;
• • Concomitantly use CYP3A4 metabolizing drugs or drugs causing drug interaction with other study drugs;
• • History of abortion one (1) month before study enrollment;
• • History of childbirth or breastfeeding 3 months before study enrollment;
• • Have hypersensitivity to any of the study drug components;
• • Patients with long-term disability, who have undergone a major surgery or any surgery in legs or major traumatism in the last 6 months;
• • Have current diagnosis of sexually transmitted disease;
• • Have used injectable hormones 3 months before study enrollment;
• • Have used hormone implant 6 months before study enrollment;
• • Have participated in another clinical trial in the last 12 months.