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

Study Overview
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Brief Summary
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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.

Conditions
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Metrorrhagia

Intervention / Treatment
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* Drug: barrier methods
* Drug: barrier methods


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dienogest 2 mg/ethynilestradiol 30 mcg;<br> | Drug: barrier methods<br> <br> |
| Active Comparator: Yasmin®<br> | Drug: barrier methods<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of intracyclic bleeding and/or spotting during the cycles 2 and 3 of treatment |  | 2 and 3 cycles (each cycle is 21 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of women with intracyclic bleeding during treatment cycles 2 to 7 |  | 2 and 7 cycles (each cycle is 21 days) |