drugset / Trial / NCT02342093

Contraceptives Containing Drospirenone and Blood Pressure

NCT02342093

RandomizedParallel-groupSingle-blind

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.

Timeline

Start
2011-01
Primary completion
2013-07
Completion
2014-09

Drugs

EvaluationDrugModalityDoseRoute
Subject ethinyl estradiol Small molecule 20 ug Oral
Subject ethinyl estradiol Small molecule 30 ug Oral
Background drospirenone Unknown 3 mg Oral

Indications