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

Instituto do Coracao69 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Masking

SINGLE

Enrollment

Conditions

Contraceptive Affecting the Autonomic Nervous System Contraceptive Affecting Blood Pressure

Interventions

After a counseling session concerning the advantages, disadvantages and side effects of contraceptive methods (COC or nonhormonal methods), the volunteers were divided into two study groups according to the method they chose to use as follows: * Case group: healthy women, users of COC containing 20 mcg ethynil estradiol and 3 mg drospirenone , 24 days of active pills, 4 days of pill-free interval (n=40). * Control group: healthy women, users of nonhormonal methods of contraception (condoms or copper IUD) (n=40). Subjects were tested once before the introduction of the contraceptive method and again after 6 months of its use.

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 20 to 40 years old * no use of hormonal contraceptives for at least 6 months before the study * need for contraceptive method * willingness to participate in the study Exclusion Criteria: * positive pregnancy test * category 3 or 4 classification on WHO's Medical Eligibility Criteria for Contraceptive * smoking * obesity * fasting glucose above 100 mg/dL * abnormalities in lipid profile * use of other medications

Outcomes

Primary Outcomes

combined hormonal oral contraceptive with drospirenone and its influence on the autonomic nervous system

The participants in this study will be 80 healthy women. After a counseling session concerning the advantages, disadvantages and side effects of contraceptive methods (COC or nonhormonal methods), the volunteers were divided into two study groups according to the method they chose to use as follows: * Case group: healthy women, users of COC containing 20 mcg EE and 3 mg DRSP (Yaz®)(n=40). * Control group: healthy women, users of nonhormonal methods of contraception (condoms or copper IUD) (n=40). The acquisition of autonomic parameters will be performed through the device Finometer.

Time frame: six months after the intervention

Secondary Outcomes

combined hormonal oral contraceptive with drospirenone and its influence on blood pressure

Time frame: six month after the intervention