Contraceptives Containing Drospirenone and Blood Pressure

University of Sao Paulo

Status and phase: Completed; Phase 4

Conditions: Contraception; Blood Pressure

Treatments: Drug: 30EE+DRSP; Drug: 20EE+DRSP

Study type: Interventional

Funder types: Other

Identifiers

NCT02342093

USP-DRSP

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

44 participants in 2 patient groups

30EE+DRSP

Active Comparator group

Description:

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

Treatment:

Drug: 30EE+DRSP

20EE+DRSP

Active Comparator group

Description:

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

Treatment:

Drug: 20EE+DRSP