Contraceptives Containing Drospirenone and Blood Pressure

Phase 4CompletedNCT02342093

University of Sao Paulo44 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

SINGLE

Enrollment

Conditions

Blood Pressure Contraception

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 24 hours