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

May 2, 2012 updated by: Marcelo Gil Nisenbaum, Instituto do Coracao
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Sao Paulo, São Paulo, Brazil, 05403-000
        • Marcelo Gil Nisenbaum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).
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 Names:
  • Brand Name in Brazil - (Yaz®)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
combined hormonal oral contraceptive with drospirenone and its influence on the autonomic nervous system
Time Frame: 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.
six months after the intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
combined hormonal oral contraceptive with drospirenone and its influence on blood pressure
Time Frame: six month after the intervention
six month after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto do Coracao

Investigators

  • Principal Investigator: Marcelo G Nisenbaum, University of Sao Paulo General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Anticipated)

May 1, 2012

Study Registration Dates

First Submitted

April 30, 2012

First Submitted That Met QC Criteria

May 2, 2012

First Posted (Estimate)

May 3, 2012

Study Record Updates

Last Update Posted (Estimate)

May 3, 2012

Last Update Submitted That Met QC Criteria

May 2, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • nisenbaum1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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