drugset / Trial / NCT02342093
Contraceptives Containing Drospirenone and Blood Pressure
Phase 4
Completed
44 enrolled
University of Sao Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ethinyl estradiol | Small molecule | 20 ug | Oral |
| Subject | ethinyl estradiol | Small molecule | 30 ug | Oral |
| Background | drospirenone | Unknown | 3 mg | Oral |