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

Istanbul Training and Research Hospital

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Contraceptive Methods Comparison

Interventions

YASMIN® (Drospirenone/Ethinyl Estradiol)DRUG

oral contraceptive pills

The Copper-T is an intrauterine device (IUD)DEVICE

intrauterine device for contraception

levonorgestrel-releasing systemDEVICE

intrauterine device

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Istanbul Training and Research Hospital

Istanbul, Turkey (Türkiye)

Outcomes

Primary Outcomes

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.

Time frame: 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

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.

Time frame: 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

Data from ClinicalTrials.gov

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