Metabolic, Androgen, Blood Coagulation Parameters and Female Sexual Function in Relation to Oral Contraceptive Use and Androgen Receptor Polymorphisms in Healthy Lithuanian Women
试验速览
- 阶段
- 不适用
- 入组人数
- 340
- 试验地点
- 1
- 主要终点
- Hirsutism
研究概览
简要总结
The aim- To evaluate the impact of combined oral contraceptives on women's psychosexual, metabolic, blood coagulation, hormonal and genetic measures.
Combined oral contraceptives (COCs) is still the most popular contraception method. It is possible to find a number of publications about their non-contraceptive benefits, also about their adverse events. Most researches are conducted during clinical trials, which are commissioned by pharmaceutical companies, in order to compare COCs of different composition. This study set out to assess the role of psychosexual, metabolic, endocrine, hormonal and genetic measures of low dose combined oral contraceptive users- 20 micrograms of Ethinylestradiol/3 mg of Drospirenone and 20 micrograms of Ethinylestradiol/75 micrograms of Gestoden. Because this study is not commercial, it is expected to obtain valuable objective data - there are very few comparative studies about the impact of COCs to woman's organism.
详细描述
The aim
To evaluate the impact of combined oral contraceptives on women's psychosexual, metabolic, blood coagulation, hormonal and genetic measures.
The objectives
- To asses the relation of AR polymorphisms to metabolic, androgen, blood coagulation parameters and sexual function in hormonal contraceptive users.
- To compare the changes of metabolic, coagulation and endocrine parameters between hormonal and non-hormonal contraceptive users.
- To assess the impact of COCs on the quality of woman's sexual life and her psychological state.
- To assess the correlation between sex hormones and women's metabolic, endocrine, psychological, sexual function.
- To evaluate the influence of COCs on the blood coagulation parameters.
- To determine the importance of androgen parameters in diagnosis of hyperandrogenism.
Materials and Methods Setting׃ The study will be conducted in Lithuanian University of Health Sciences during the period from 2013 to 2016 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18 - 40 years old women applying to obstetrician-gynaecologist for contraception use or for preventive health care and giving their consent to participate in the study (who signed The Informed Consent Form) will be eligible to participate in the study. It is important to note that these women should not have underlying medical conditions (chronic non - infection diseases, chronic or acute infection diseases).
- •Not using hormonal contraception for 6 months or more.
排除标准
- •Women applying for obstetrician-gynaecologist consultation on gynaecological pathology.
- •Women with underlying medical conditions (chronic non - infection diseases, chronic or acute infection diseases).
- •Women, planning to get pregnant during the 12 months.
- •Pregnant women (suspected or confirmed pregnancy).
结局指标
主要结局
Hirsutism
时间窗: 2 years
The expression of terminal hair growth using Ferriman- Gallwey scoring system in Lithuanian women will be assessed.
次要结局
- Blood coagulation parameters and hormonal contraception(3 years)
- Free androgen Index(3 years)
- Lipids concentration(3 years)
- Homeostasis model assessment(3 years)
研究者
Lina Ciaplinskiene
PhD student
Lithuanian University of Health Sciences