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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
Subjects were tested once before the introduction of the contraceptive method and again after 6 months of its use. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
The acquisition of autonomic parameters will be performed through the device Finometer. | six months after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| combined hormonal oral contraceptive with drospirenone and its influence on blood pressure | six month after the intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marcelo G Nisenbaum | University of Sao Paulo General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marcelo Gil Nisenbaum | SĂŁo Paulo | SĂŁo Paulo | 05403-000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19828840 | Background | 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. | |
| 11004135 | 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. |
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|
|
| ID | Term |
|---|---|
| D003270 | Contraceptive Agents |
| C534342 | drospirenone and ethinyl estradiol combination |
| ID | Term |
|---|---|
| D012102 | Reproductive Control Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045506 | Therapeutic Uses |
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