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

• Sponsor: Instituto do Coracao (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01590849
• Collaborator: (none)
• Enrollment: 69
• Location: 1
• Arms: 2

Study Details

Study Description

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.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 69 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Official Title: Assessment of Autonomic Tone in Normotensive Women Using Combined Hormonal Oral Contraceptive Containing Drospirenone
• Study Start Date: Jan 1, 2011
• Anticipated Primary Completion Date: May 1, 2012

Arms and Interventions

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®)

Outcome Measures

Primary Outcome Measures

1. combined hormonal oral contraceptive with drospirenone and its influence on the autonomic nervous system [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.

Secondary Outcome Measures

1. combined hormonal oral contraceptive with drospirenone and its influence on blood pressure [six month after the intervention]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

• Carter JR, Klein JC, Schwartz CE. Effects of oral contraceptives on sympathetic nerve activity during orthostatic stress in young, healthy women. Am J Physiol Regul Integr Comp Physiol. 2010 Jan;298(1):R9-R14. doi: 10.1152/ajpregu.00554.2009. Epub 2009 Oct 14.
• Minson CT, Halliwill JR, Young TM, Joyner MJ. Sympathetic activity and baroreflex sensitivity in young women taking oral contraceptives. Circulation. 2000 Sep 26;102(13):1473-6.

• 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
• Other Study ID Numbers: nisenbaum1
• First Posted: May 3, 2012
• Last Update Posted: May 3, 2012
• Last Verified: May 1, 2012

• Keywords provided by 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: contraceptive agents; autonomic nervous system; blood pressure; risk
• Additional relevant MeSH terms: Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined

Study Results

No Results Posted as of May 3, 2012