Comparison of Levonorgestrel Intrauterine System, Copper T Intrauterine Device and Oral Contraceptives on Life Quality

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of Levonorgestrel Intrauterine System, Copper T Intrauterine Device and Oral Contraceptives on Life Quality

Conditions
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Contraceptive Methods Comparison

Intervention / Treatment
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* Drug: YASMIN® (Drospirenone/Ethinyl Estradiol)
* Device: The Copper-T is an intrauterine device (IUD)
* Device: levonorgestrel-releasing system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women who desire contraception Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Levonorgestrel releasing intrauterine device, contraception<br>LNG-IUS - Mirena ®,20μgr, once intrauterine insertion per 5 year, 1 year | Drug: YASMIN® (Drospirenone/Ethinyl Estradiol)<br>* oral contraceptive pills<br>Device: The Copper-T is an intrauterine device (IUD)<br>* intrauterine device for contraception<br>Device: levonorgestrel-releasing system<br>* intrauterine device<br>* Other names: Miirena;|
| Experimental: YASMIN® (Drospirenone/Ethinyl Estradiol), contraception<br>oral, once a day, 1 year | Drug: YASMIN® (Drospirenone/Ethinyl Estradiol)<br>* oral contraceptive pills<br>Device: The Copper-T is an intrauterine device (IUD)<br>* intrauterine device for contraception<br>Device: levonorgestrel-releasing system<br>* intrauterine device<br>* Other names: Miirena;|
| Experimental: Copper T 380 A , contraception<br>intrauterine device, once per 10 year, 1 year period | Drug: YASMIN® (Drospirenone/Ethinyl Estradiol)<br>* oral contraceptive pills<br>Device: The Copper-T is an intrauterine device (IUD)<br>* intrauterine device for contraception<br>Device: levonorgestrel-releasing system<br>* intrauterine device<br>* Other names: Miirena;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid profile (HDL,VLDL,IDL,LDL,Lp(a),VLDL)Lng-ius users, Copper-iud users and combined oral contraceptive users (composite measurement) | 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. | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| coagulation parameters(composite measurement) | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lipid profile, bleeding scores, menstrual pattern, beneficial, side effects, changes in a year period