Contraceptives Containing Drospirenone and Blood Pressure

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02342093

Enrollment

Registered

2015-01-19

Start date

2011-01-31

Completion date

2014-09-30

Last updated

2015-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure, Contraception

Keywords

Ambulatory Blood Pressure Monitoring, Drospirenone, Oral contraceptive

Brief summary

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.

Interventions

DRUG30EE+DRSP

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

DRUG20EE+DRSP

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 35 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Blood pressure	24 hours	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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026