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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Contraceptive Affecting the Autonomic Nervous System Contraceptive Affecting Blood Pressure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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No hormonal contraception

Group Type NO_INTERVENTION

No interventions assigned to this group

Hormonal Contraceptive

healthy women, users of COC containing 20 mcg EE and 3 mg DRSP (Yaz®), 24 days of active pills, 4 days of pill-free interval (n=40).

Group Type ACTIVE_COMPARATOR

Contraceptives, Oral, Combined (Yaz®)

Intervention Type DRUG

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.

Interventions

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Contraceptives, Oral, Combined (Yaz®)

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.

Intervention Type DRUG

Other Intervention Names

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Brand Name in Brazil - (Yaz®)

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Marcelo Gil Nisenbaum

post graduate and contributor to the medical clinic for family planning of the Department of Gynecology of Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

Responsibility Role PRINCIPAL_INVESTIGATOR