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

Phase 3

• Conditions: Contraceptive Affecting the Autonomic Nervous System; Contraceptive Affecting Blood Pressure
• Interventions: Drug: Contraceptives, Oral, Combined (Yaz®)

• Registration Number: NCT01590849
• Lead Sponsor: Instituto do Coracao

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2012-04-30
• Status Verified: 2012-05
• Primary Completion: 2012-05
• Study First Submitted QC: 2012-05-02
• Last Update Submitted: 2012-05-02
• Study First Posted: 2012-05-03
• Last Update Posted: 2012-05-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 69

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hormonal Contraceptive	Contraceptives, Oral, Combined (Yaz®)	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).

Primary Outcome Measures

Name	Time	Method
combined hormonal oral contraceptive with drospirenone and its influence on the autonomic nervous system	six months after the intervention	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.

Secondary Outcome Measures

Name	Time	Method
combined hormonal oral contraceptive with drospirenone and its influence on blood pressure	six month after the intervention

Trial Locations

Locations (1)

Marcelo Gil Nisenbaum; 🇧🇷 Sao Paulo, São Paulo, Brazil