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| Name | Class |
|---|---|
| Conselho Nacional de Desenvolvimento Científico e Tecnológico | OTHER_GOV |
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Background: Drospirenone (DRSP) seems to have a favorable effect on blood pressure (BP); however, when associated with ethinylestradiol (EE), this effect does not seem to occur. This study has the objective to assess possible differences in BP associated with the use of COCs containing DRSP with different doses of ethinylestradiol.
Materials and methods: This open-label parallel-group randomized clinical trial involved women randomized to use either 30 mcg of EE+DRSP (n=22) or 20 mcg of EE+DRSP (n=22). Daytime, nighttime and 24-hour BP were evaluated by ambulatory blood pressure monitoring (ABPM) at the beginning of the trial and six months after drug therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 30EE+DRSP | Active Comparator | Combined oral contraceptive containing 30 mcg of ethinylestradiol + 3 mg of drospirenone (30EE+DRSP), 1 pill once a day with a pause of seven days between the blisters for 6 months |
|
| 20EE+DRSP | Active Comparator | Combined oral contraceptive containing 20 mcg of ethinylestradiol + 3 mg of drospirenone (20EE+DRSP), 1 pill once a day with a pause of four days between the blisters for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 30EE+DRSP | Drug | Combined oral contraceptive containing 30 mcg of ethinylestradiol + 3 mg of drospirenone (30EE+DRSP), 1 pill once a day with a pause of seven days between the blisters for 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | Twenty-four-hour mean systolic blood pressure (SBP), 24-hour mean diastolic blood pressure (DBP), and day and nighttime SBP and DBP were measured by ambulatory blood pressure monitoring | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carolina S Vieira, MD, PhD | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Sao Paulo | Ribeirão Preto | São Paulo | 14049-900 | Brazil |
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| 20EE+DRSP | Drug | Combined oral contraceptive containing 30 mcg of ethinylestradiol + 3 mg of drospirenone (20EE+DRSP), 1 pill once a day with a pause of four days between the blisters for 6 months |
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