Comparison of Levonorgestrel Intrauterine System, Copper T Intrauterine Device and Oral Contraceptives on Life Quality
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Lipid profile (HDL,VLDL,IDL,LDL,Lp(a),VLDL)Lng-ius users, Copper-iud users and combined oral contraceptive users (composite measurement)
研究概览
简要总结
Oral combined contraceptives(OC) have both progesterone and estrogen inside. Levonorgestrel-releasing intrauterine device(LNG_IUS) has only progestagen.
Copper IUD does not have any hormonal molecule inside.
- Hypothesis is OC has more systemic beneficial or side effects than LNG_IUS or copper IUD. LNG_IUS has more local effects than copper IUD.
- Study reflects the beneficial or side effects of estrogen+progestagen pills and only progestogen inside device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women who desire contraception
排除标准
- •Women with large fibroids,abnormal uterine bleeding including heavy menstrual bleeding or using any contraceptive pills during the previous 3 months were excluded from the study. Other exclusion criteria were pelvic inflammatory disease, pregnancy, genital tumor or thromboembolic disease.
研究组 & 干预措施
Levonorgestrel releasing intrauterine device, contraception
LNG-IUS - Mirena ®,20μgr, once intrauterine insertion per 5 year, 1 year
干预措施: levonorgestrel-releasing system (Device)
Levonorgestrel releasing intrauterine device, contraception
LNG-IUS - Mirena ®,20μgr, once intrauterine insertion per 5 year, 1 year
干预措施: YASMIN® (Drospirenone/Ethinyl Estradiol) (Drug)
Levonorgestrel releasing intrauterine device, contraception
LNG-IUS - Mirena ®,20μgr, once intrauterine insertion per 5 year, 1 year
干预措施: The Copper-T is an intrauterine device (IUD) (Device)
YASMIN® (Drospirenone/Ethinyl Estradiol), contraception
oral, once a day, 1 year
干预措施: YASMIN® (Drospirenone/Ethinyl Estradiol) (Drug)
YASMIN® (Drospirenone/Ethinyl Estradiol), contraception
oral, once a day, 1 year
干预措施: The Copper-T is an intrauterine device (IUD) (Device)
YASMIN® (Drospirenone/Ethinyl Estradiol), contraception
oral, once a day, 1 year
干预措施: levonorgestrel-releasing system (Device)
Copper T 380 A , contraception
intrauterine device, once per 10 year, 1 year period
干预措施: YASMIN® (Drospirenone/Ethinyl Estradiol) (Drug)
Copper T 380 A , contraception
intrauterine device, once per 10 year, 1 year period
干预措施: The Copper-T is an intrauterine device (IUD) (Device)
Copper T 380 A , contraception
intrauterine device, once per 10 year, 1 year period
干预措施: levonorgestrel-releasing system (Device)
结局指标
主要结局
Lipid profile (HDL,VLDL,IDL,LDL,Lp(a),VLDL)Lng-ius users, Copper-iud users and combined oral contraceptive users (composite measurement)
时间窗: Change from Baseline HDL,Very-low-density lipoprotein (VLDL),IDL,Low-density lipoprotein (LDL),Lp(a),VLDL concentrations at 3 months; Baseline to 6 months, Baseline to 12 months of outcome will have assessed
60 lng-ius users, 60 Copper iud users and 60 combined oral contraceptive users will compared with total lipoprotein, high-density lipoprotein (HDL), low-density lipoprotein (LDL), very-low-density lipoprotein (VLDL), lipoprotein(a) (Lp(a)), intermediate-density lipoprotein (IDL ), HDL subclasses , LDL subclasses , VLDL subclasses ,values at 3-6-12 months follow up.
次要结局
- coagulation parameters(composite measurement)(Change from Baseline aPTT, prothrombin time, INR, D-dimer,factor VIII, fibrinogen, platelet counts values at 3 months; Baseline to 6 months, Baseline to 12 months of outcome will have assessed)
研究者
Cihangir Uzunçakmak
Medical Doctor, OB/GYN
Istanbul Training and Research Hospital