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

• Status: Withdrawn
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

This trial will study the percentage of women with at least one occurrence of intracyclic bleeding (bleeding and/or spotting) during the cycles 2 and 3 of treatment with test or reference drug.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eurofarma Laboratorios S.A.
• Treatments: Dienogest

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.