Text Size

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
  Purpose

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.


Condition Intervention Phase
Contraceptive Affecting the Autonomic Nervous System
Contraceptive Affecting Blood Pressure
 Drug: Contraceptives, Oral, Combined (Yaz®)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Assessment of Autonomic Tone in Normotensive Women Using Combined Hormonal Oral Contraceptive Containing Drospirenone

Resource links provided by NLM:

MedlinePlus related topics: Birth Control
U.S. FDA Resources

Further study details as provided by Instituto do Coracao:

Primary Outcome Measures:
  • 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.



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

Enrollment: 69
Study Start Date: January 2011
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Brand Name in Brazil - (Yaz®)

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01590849

Locations
Brazil
Marcelo Gil Nisenbaum
Sao Paulo, São Paulo, Brazil, 05403-000
Sponsors and Collaborators
Instituto do Coracao
Investigators
Principal Investigator: Marcelo G Nisenbaum University of Sao Paulo General Hospital
  More Information

Publications:

Responsible Party: 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, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01590849     History of Changes
Other Study ID Numbers: nisenbaum1
Study First Received: April 30, 2012
Last Updated: May 2, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by Instituto do Coracao:
contraceptive agents
autonomic nervous system
blood pressure
risk

Additional relevant MeSH terms:
Contraceptive Agents
Contraceptives, Oral
Contraceptives, Oral, Combined
Contraceptives, Oral, Hormonal
Drospirenone
Reproductive Control Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Aldosterone Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on May 23, 2013