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

NCT01590849 | Unknown Phase 3 DMC

• 1 other identifier: nisenbaum1
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Contraceptive Affecting the Autonomic Nervous System; Contraceptive Affecting Blood Pressure

Keywords

contraceptive agents; autonomic nervous system; blood pressure; risk

Outcome Measures

Primary Outcomes (1)

• combined hormonal oral contraceptive with drospirenone and its influence on the autonomic nervous system

  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 Outcomes (1)

• combined hormonal oral contraceptive with drospirenone and its influence on blood pressure

  six month after the intervention

Study Arms (2)

No hormonal contraception

NO INTERVENTION

Hormonal Contraceptive

ACTIVE COMPARATOR

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®)

Interventions

Contraceptives, Oral, Combined (Yaz®) DRUG

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.

Also known as: Brand Name in Brazil - (Yaz®)

Hormonal Contraceptive

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto do Coracao: lead

Study Sites (1)

Marcelo Gil Nisenbaum

São Paulo, São Paulo, 05403-000, Brazil

Location

Related Publications (2)

• 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.

  PMID: 19828840 BACKGROUND

• 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. doi: 10.1161/01.cir.102.13.1473.

  PMID: 11004135 BACKGROUND

MeSH Terms

Interventions

Contraceptive Agents; drospirenone and ethinyl estradiol combination

Intervention Hierarchy (Ancestors)

Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses

Study Officials

• Marcelo G Nisenbaum

  University of Sao Paulo General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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

Study Record Dates

• First Submitted: April 30, 2012
• First Posted: May 3, 2012
• Study Start: January 1, 2011
• Primary Completion: May 1, 2012
• Last Updated: May 3, 2012

Record last verified: 2012-05

Locations

BR (1)