Contraceptives Containing Drospirenone and Blood Pressure

NCT ID: NCT02342093

Last Updated: 2015-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2014-09-30

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.

Conditions

Blood Pressure; Contraception

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

30EE+DRSP

Intervention Type: DRUG

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

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

Group Type: ACTIVE_COMPARATOR

20EE+DRSP

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

20EE+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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role: collaborator

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Carolina Sales Vieira

Professor of Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carolina S Vieira, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

University of Sao Paulo

Ribeirão Preto, São Paulo, Brazil

Countries

Brazil

Other Identifiers

USP-DRSP

Identifier Type: -

Identifier Source: org_study_id