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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Marcelo Gil Nisenbaum, University of Sao Paulo General Hospital

ClinicalTrials.gov Identifier:

NCT01590849

First received: April 30, 2012

Last updated: May 2, 2012

Last verified: May 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

April 30, 2012

Last Updated Date

May 2, 2012

Start Date ^ICMJE

January 2011

Estimated Primary Completion Date

May 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

combined hormonal oral contraceptive with drospirenone and its influence on the autonomic nervous system [ Time Frame: six months after the intervention ] [ Designated as safety issue: Yes ]

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01590849 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

combined hormonal oral contraceptive with drospirenone and its influence on blood pressure [ Time Frame: six month after the intervention ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)

Condition ^ICMJE

Contraceptive Affecting the Autonomic Nervous System
Contraceptive Affecting Blood Pressure

Intervention ^ICMJE

Drug: 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.

Other Name: Brand Name in Brazil - (Yaz®)

Study Arm (s)

No Intervention: No hormonal contraception
Active Comparator: 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).

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

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

May 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

20 Years to 40 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Brazil

Administrative Information

NCT Number ^ICMJE

NCT01590849

Other Study ID Numbers ^ICMJE

nisenbaum1

Has Data Monitoring Committee

Yes

Responsible Party

Marcelo Gil Nisenbaum, University of Sao Paulo General Hospital

Study Sponsor ^ICMJE

Instituto do Coracao

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Marcelo G Nisenbaum

University of Sao Paulo General Hospital

Information Provided By

Instituto do Coracao

Verification Date

May 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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