Contraceptives Containing Drospirenone and Blood Pressure

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Sao Paulo
• Collaborator: Conselho Nacional de Desenvolvimento Científico e Tecnológico
• Treatments: Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined; Drospirenone; Ethinyl Estradiol

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