Assessment of Autonomic Tone in Normotensive Women Using Combined Hormonal Oral Contraceptive Containing Drospirenone
试验速览
- 阶段
- 3 期
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- combined hormonal oral contraceptive with drospirenone and its influence on the autonomic nervous system
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •positive pregnancy test
- •category 3 or 4 classification on WHO's Medical Eligibility Criteria for Contraceptive
- •fasting glucose above 100 mg/dL
- •abnormalities in lipid profile
- •use of other medications
研究组 & 干预措施
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).
干预措施: Contraceptives, Oral, Combined (Yaz®) (Drug)
结局指标
主要结局
combined hormonal oral contraceptive with drospirenone and its influence on the autonomic nervous system
时间窗: 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.
次要结局
- combined hormonal oral contraceptive with drospirenone and its influence on blood pressure(six month after the intervention)
研究者
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