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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Instituto do Coracao.
Recruitment status was  Active, not recruiting
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

April 30, 2012
May 2, 2012
January 2011
May 2012   (final data collection date for primary outcome measure)
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.

Same as current
Complete list of historical versions of study NCT01590849 on ClinicalTrials.gov Archive Site
combined hormonal oral contraceptive with drospirenone and its influence on blood pressure [ Time Frame: six month after the intervention ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Assessment of Autonomic Tone in Normotensive Women Using Combined Hormonal Oral Contraceptive Containing Drospirenone
Assessment of Autonomic Tone in Normotensive Women Using Combined Hormonal Oral Contraceptive Containing Drospirenone

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
  • Contraceptive Affecting the Autonomic Nervous System
  • Contraceptive Affecting Blood Pressure
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®)
  • 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®)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
69
Not Provided
May 2012   (final data collection date for primary outcome measure)

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
Female
20 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01590849
nisenbaum1
Yes
Marcelo Gil Nisenbaum, University of Sao Paulo General Hospital
Instituto do Coracao
Not Provided
Principal Investigator: Marcelo G Nisenbaum University of Sao Paulo General Hospital
Instituto do Coracao
May 2012

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