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

Sponsor
Istanbul Training and Research Hospital (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01805817
Collaborator
(none)
0
1
3

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.

  • 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: YASMIN® (Drospirenone/Ethinyl Estradiol)
  • Device: The Copper-T is an intrauterine device (IUD)
  • Device: levonorgestrel-releasing system
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparison of Levonorgestrel Intrauterine System, Copper T Intrauterine Device and Oral Contraceptives on Life Quality
Study Start Date :
Dec 1, 2012
Anticipated Primary Completion Date :
Dec 1, 2013

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:
  • Miirena
  • 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:
  • Miirena
  • 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:
  • Miirena
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    1. 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

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Responsible Party:
    Cihangir Uzunçakmak, Medical Doctor, OB/GYN, Istanbul Training and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT01805817
    Other Study ID Numbers:
    • cuzuncakmak1907
    First Posted:
    Mar 6, 2013
    Last Update Posted:
    Aug 13, 2020
    Last Verified:
    Aug 1, 2020
    Keywords provided by Cihangir Uzunçakmak, Medical Doctor, OB/GYN, Istanbul Training and Research Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 13, 2020