Clinical trial NCT01805817: Comparison of Levonorgestrel Intrauterine System, Copper T Intrauterine Device and Oral Contraceptives on Life Quality
Official title: Comparison of Levonorgestrel Intrauterine System, Copper T Intrauterine Device and Oral Contraceptives on Life Quality
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Contraceptive Methods Comparison
Keywords: lipid profile
bleeding scores
menstrual pattern
beneficial
side effects
changes in a year period
Lead sponsor: Istanbul Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2013-03-06
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Lipid profile (HDL,VLDL,IDL,LDL,Lp(a),VLDL)Lng-ius users, Copper-iud users and combined oral contraceptive users (composite measurement)
timeFrame: 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 outcomes:
measure: coagulation parameters(composite measurement)
timeFrame: 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
Other outcomes:
measure: menstrual pattern and bleeding scores(composite measurement)
timeFrame: Change from Baseline pictorial blood scoring system scores at 3 months, Baseline to 6 months, Baseline to 12 months will be assessed
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Training and Research Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.