Clinical Trial With Combination of Dienogest/Ethytnilestradiol and Drosperidona/Ethyniestradiol
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ClinicalTrials.gov Identifier: NCT01557023
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Ages Eligible for Study:
18 Years to 35 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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.