Comparison of Levonorgestrel Intrauterine System, Copper T Intrauterine Device and Oral Contraceptives on Life Quality
- Conditions
- Contraceptive Methods Comparison
- Interventions
- Device: The Copper-T is an intrauterine device (IUD)Device: levonorgestrel-releasing system
- Registration Number
- NCT01805817
- Lead Sponsor
- Istanbul Training and Research Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
- women who desire contraception
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Levonorgestrel releasing intrauterine device, contraception The Copper-T is an intrauterine device (IUD) LNG-IUS - Mirena ®,20μgr, once intrauterine insertion per 5 year, 1 year Levonorgestrel releasing intrauterine device, contraception levonorgestrel-releasing system LNG-IUS - Mirena ®,20μgr, once intrauterine insertion per 5 year, 1 year YASMIN® (Drospirenone/Ethinyl Estradiol), contraception The Copper-T is an intrauterine device (IUD) oral, once a day, 1 year YASMIN® (Drospirenone/Ethinyl Estradiol), contraception levonorgestrel-releasing system oral, once a day, 1 year Copper T 380 A , contraception The Copper-T is an intrauterine device (IUD) intrauterine device, once per 10 year, 1 year period Copper T 380 A , contraception levonorgestrel-releasing system intrauterine device, once per 10 year, 1 year period Levonorgestrel releasing intrauterine device, contraception YASMIN® (Drospirenone/Ethinyl Estradiol) LNG-IUS - Mirena ®,20μgr, once intrauterine insertion per 5 year, 1 year YASMIN® (Drospirenone/Ethinyl Estradiol), contraception YASMIN® (Drospirenone/Ethinyl Estradiol) oral, once a day, 1 year Copper T 380 A , contraception YASMIN® (Drospirenone/Ethinyl Estradiol) intrauterine device, once per 10 year, 1 year period
- Primary Outcome Measures
Name Time Method Lipid profile (HDL,VLDL,IDL,LDL,Lp(a),VLDL)Lng-ius users, Copper-iud users and combined oral contraceptive users (composite measurement) 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.
- Secondary Outcome Measures
Name Time Method 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 60 lng-ius users, 60 Copper iud users and 60 combined oral contraceptive users will compared with activated partial thromboplastin time (aPTT), prothrombin time, international normalized ratio(INR), D-dimer,factor VIII, fibrinogen, platelet counts values with each other at 3-6-12 months follow up.
Trial Locations
- Locations (1)
Istanbul Training and Research Hospital
🇹🇷Istanbul, Turkey
Istanbul Training and Research Hospital🇹🇷Istanbul, Turkey