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Trial record 12 of 53 for:    DROSPIRENONE AND ETHINYL ESTRADIOL AND containing

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01590849
Recruitment Status : Unknown
Verified May 2012 by Marcelo Gil Nisenbaum, University of Sao Paulo General Hospital.
Recruitment status was:  Active, not recruiting
First Posted : May 3, 2012
Last Update Posted : May 3, 2012
Sponsor:
Information provided by (Responsible Party):
Marcelo Gil Nisenbaum, University of Sao Paulo General Hospital

Tracking Information
First Submitted Date  ICMJE April 30, 2012
First Posted Date  ICMJE May 3, 2012
Last Update Posted Date May 3, 2012
Study Start Date  ICMJE January 2011
Estimated Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2012)
combined hormonal oral contraceptive with drospirenone and its influence on blood pressure [ Time Frame: six month after the intervention ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (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 Arms  ICMJE
  • 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 Unknown status
Actual Enrollment  ICMJE
 (submitted: May 2, 2012)
69
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01590849
Other Study ID Numbers  ICMJE nisenbaum1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
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
PRS Account 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