NCT02342093|CompletedPhase 4
Contraceptives Containing Drospirenone and Blood Pressure
Effects of Two Contraceptives Containing Drospirenone on Blood Pressure in Normotensive Women: a Randomized Controlled Trial
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Effects of Two Contraceptives Containing Drospirenone on Blood Pressure in Normotensive Women: a Randomized Controlled Trial
Sponsor study identifier
interventional
44
1 country
1
Study Start
January 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2013
Actual (reported)Study Completion
September 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2014
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2011
Date type not reportedThis date has not been verified as actual or estimated.
July 2013
Actual (reported)September 2014
Actual (reported)January 14, 2015
Actual (reported)January 19, 2015
Actual (reported)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
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
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
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
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
University of Sao Paulo
Ribeirão Preto, São Paulo, 14049-900, Brazil
Carolina S Vieira, MD, PhD
University of Sao Paulo
44 participants (actual enrollment reported by the registry).
First Submitted
January 14, 2015
First Posted
January 19, 2015
Study Start
January 2011
Date type not reportedThis date has not been verified as actual or estimated.
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Primary Completion
July 2013
Actual (reported)Study Completion
September 2014
Actual (reported)Last Updated
January 19, 2015
Record last verified: 2015-01
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Source: ClinicalTrials.gov.
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