Contraceptive Affecting Blood Pressure Clinical Trial
Official title:
Assessment of Autonomic Tone in Normotensive Women Using Combined Hormonal Oral Contraceptive Containing Drospirenone
| Verified date | May 2012 |
| Source | Instituto do Coracao |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Brazil: Ethics Committee |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 69 |
| Est. completion date | |
| Est. primary completion date | May 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 20 Years to 40 Years |
| Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Marcelo Gil Nisenbaum | Sao Paulo | São Paulo |
| Lead Sponsor | Collaborator |
|---|---|
| Instituto do Coracao |
Brazil,
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. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Yes |
| Secondary | combined hormonal oral contraceptive with drospirenone and its influence on blood pressure | six month after the intervention | Yes |