drugset / Trial / NCT01590849

Assessment of Autonomic Tone in Normotensive Women Using Combined Hormonal Oral Contraceptive Containing Drospirenone

NCT01590849

Phase 3 Unknown 69 enrolled Instituto do Coracao
Non-randomizedParallel-groupSingle-blind

Summary

The use of combined oral contraceptives has been associated with increased risk of adverse cardiovascular events. The exact mechanism by which these drugs exert this influence is uncertain. It is possible that changes in autonomic nervous system are involved. The objective of these study was to evaluate the effect of the use of a contraceptive containing 20 mcg of ethinyl estradiol and 3mg of drospirenone in the autonomic nervous system in healthy women. Few studies have been conducted in the field of hormonal contraception and evaluation of the autonomic nervous system work and no prospective, controlled study was published so far. These study will be the first.

Timeline

Start
2011-01
Primary completion
2012-05
Completion

Drugs

EvaluationDrugModalityDoseRoute
Comparator drospirenone Unknown 3 mg Oral
Comparator ethinyl estradiol Small molecule 20 ug Oral

Indications

No indication recorded.