Contraceptives Containing Drospirenone and Blood Pressure

Phase 4

Completed

• Conditions: Blood Pressure; Contraception
• Interventions: Drug: 30EE+DRSP; Drug: 20EE+DRSP

• Registration Number: NCT02342093
• Lead Sponsor: University of Sao Paulo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2013-07
• Study Completion: 2014-09
• Status Verified: 2015-01
• Study First Submitted: 2015-01-14
• Study First Submitted QC: 2015-01-14
• Last Update Submitted: 2015-01-14
• Study First Posted: 2015-01-19
• Last Update Posted: 2015-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 44

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
30EE+DRSP	30EE+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
20EE+DRSP	20EE+DRSP	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

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Sao Paulo; 🇧🇷 Ribeirão Preto, SP, Brazil