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

Instituto do Coracao

Status and phase: Unknown; Phase 3

Conditions: Contraceptive Affecting the Autonomic Nervous System; Contraceptive Affecting Blood Pressure

Treatments: Drug: Contraceptives, Oral, Combined (Yaz®)

Study type: Interventional

Funder types: Other

Identifiers

NCT01590849

nisenbaum1

Details and patient eligibility

About

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.

Enrollment: 69 patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

69 participants in 2 patient groups

No hormonal contraception

No Intervention group

Hormonal Contraceptive

Active Comparator group

Description:

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).

Treatment:

Drug: Contraceptives, Oral, Combined (Yaz®)