Assessment of Autonomic Tone in Normotensive Women Using Combined Hormonal Oral Contraceptive Containing Drospirenone
This trial is active, not recruiting.
|Conditions||contraceptive affecting the autonomic nervous system, contraceptive affecting blood pressure|
|Treatment||contraceptives, oral, combined (yaz®)|
|Sponsor||Instituto do Coracao|
|Start date||January 2011|
|End date||May 2012|
|Trial size||69 participants|
|Trial identifier||NCT01590849, nisenbaum1|
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.
|Endpoint classification||safety study|
|Intervention model||parallel assignment|
|Masking||single blind (outcomes assessor)|
combined hormonal oral contraceptive with drospirenone and its influence on the autonomic nervous system
time frame: six months after the intervention
combined hormonal oral contraceptive with drospirenone and its influence on blood pressure
time frame: six month after the intervention
Female participants from 20 years up to 40 years old.
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
|Official title||Assessment of Autonomic Tone in Normotensive Women Using Combined Hormonal Oral Contraceptive Containing Drospirenone|
|Principal investigator||Marcelo G Nisenbaum|
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