Comparison of Levonorgestrel Intrauterine System, Copper T Intrauterine Device and Oral Contraceptives on Life Quality
Study Details
Study Description
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.
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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.
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Study reflects the beneficial or side effects of estrogen+progestagen pills and only progestogen inside device.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Levonorgestrel releasing intrauterine device, contraception LNG-IUS - Mirena ®,20μgr, once intrauterine insertion per 5 year, 1 year |
Drug: YASMIN® (Drospirenone/Ethinyl Estradiol)
oral contraceptive pills
Device: The Copper-T is an intrauterine device (IUD)
intrauterine device for contraception
Device: levonorgestrel-releasing system
intrauterine device
Other Names:
|
Experimental: YASMIN® (Drospirenone/Ethinyl Estradiol), contraception oral, once a day, 1 year |
Drug: YASMIN® (Drospirenone/Ethinyl Estradiol)
oral contraceptive pills
Device: The Copper-T is an intrauterine device (IUD)
intrauterine device for contraception
Device: levonorgestrel-releasing system
intrauterine device
Other Names:
|
Experimental: Copper T 380 A , contraception intrauterine device, once per 10 year, 1 year period |
Drug: YASMIN® (Drospirenone/Ethinyl Estradiol)
oral contraceptive pills
Device: The Copper-T is an intrauterine device (IUD)
intrauterine device for contraception
Device: levonorgestrel-releasing system
intrauterine device
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Other Outcome Measures
- menstrual pattern and bleeding scores(composite measurement) [Change from Baseline pictorial blood scoring system scores at 3 months, Baseline to 6 months, Baseline to 12 months will be assessed]
60 lng-ius users, 60 Copper iud users and 60 combined oral contraceptive users menstrual pattern will be recorded and menstrual bleeding scores will be measured by pictorial blood scoring system and it will be compared with each other at 3-6-12 months follow up.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Istanbul Training and Research Hospital | Istanbul | Turkey | 34098 |
Sponsors and Collaborators
- Istanbul Training and Research Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Haliloglu B, Celik A, Ilter E, Bozkurt S, Ozekici U. Comparison of uterine artery blood flow with levonorgestrel intrauterine system and copper intrauterine device. Contraception. 2011 Jun;83(6):578-81. doi: 10.1016/j.contraception.2010.09.001. Epub 2010 Oct 18.
- Mansour D, Gemzell-Danielsson K, Inki P, Jensen JT. Fertility after discontinuation of contraception: a comprehensive review of the literature. Contraception. 2011 Nov;84(5):465-77. doi: 10.1016/j.contraception.2011.04.002. Epub 2011 Jun 8. Review.
- Sayed GH, Zakherah MS, El-Nashar SA, Shaaban MM. A randomized clinical trial of a levonorgestrel-releasing intrauterine system and a low-dose combined oral contraceptive for fibroid-related menorrhagia. Int J Gynaecol Obstet. 2011 Feb;112(2):126-30. doi: 10.1016/j.ijgo.2010.08.009. Epub 2010 Nov 19.
- cuzuncakmak1907