Contraceptives Containing Drospirenone and Blood Pressure

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Two Contraceptives Containing Drospirenone on Blood Pressure in Normotensive Women: a Randomized Controlled Trial

Conditions
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Blood Pressure, Contraception

Intervention / Treatment
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* Drug: 30EE+DRSP
* Drug: 20EE+DRSP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: sexually active women who did not wish to become pregnant, aged between 18 and 35, with menstrual cycles lasting between 24 and 32 days, body mass index (BMI) between 18.0 and 29.9 kg/m2 Exclusion Criteria: smoking, use of drugs and/or alcohol, clinical and/or laboratory signs of hyperandrogenism, use of hormonal contraception within six months before the initiation of the study, presence of chronic and/or acute inflammatory processes, use of medications with endothelial effects (e.g., statins), breastfeeding or having stopped breastfeeding within two months before the initiation of the study, medical conditions classified as category 3 or 4 according to the WHO medical eligibility criteria for contraceptive prescription

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 30EE+DRSP<br>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 | Drug: 30EE+DRSP<br>* 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<br>|
| Active Comparator: 20EE+DRSP<br>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 | Drug: 20EE+DRSP<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ambulatory Blood Pressure Monitoring, Drospirenone, Oral contraceptive