Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01805817
Recruitment Status : Unknown
Verified March 2013 by Cihangir Uzunçakmak, Istanbul Training and Research Hospital.
Recruitment status was:  Recruiting
First Posted : March 6, 2013
Last Update Posted : March 7, 2013
Sponsor:
Information provided by (Responsible Party):
Cihangir Uzunçakmak, Istanbul Training and Research Hospital

Tracking Information
First Submitted Date  ICMJE February 15, 2013
First Posted Date  ICMJE March 6, 2013
Last Update Posted Date March 7, 2013
Study Start Date  ICMJE December 2012
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2013)
Lipid profile (HDL,VLDL,IDL,LDL,Lp(a),VLDL)Lng-ius users, Copper-iud users and combined oral contraceptive users (composite measurement) [ 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 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 5, 2013)
lipid profile (HDL,VLDL,IDL,LDL,Lp(a),VLDL) [ Time Frame: Change from Baseline HDL,VLDL,IDL,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 (HDL2 and HDL3), LDL subclasses (LDL1, LDL2, LDL3, and LDL4), VLDL subclasses (VLDL1, VLDL2, and VLDL3),values at 3-6-12 months follow up.
Change History Complete list of historical versions of study NCT01805817 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2013)
coagulation parameters(composite measurement) [ 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 ]
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2013)
coagulation parameters [ 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 ]
60 lng-ius users, 60 Copper iud users and 60 combined oral contraceptive users will compared with aPTT, prothrombin time, INR, D-dimer,factor VIII, fibrinogen, platelet counts values with each other at 3-6-12 months follow up.
Current Other Pre-specified Outcome Measures
 (submitted: March 6, 2013)
menstrual pattern and bleeding scores(composite measurement) [ Time Frame: 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.
Original Other Pre-specified Outcome Measures
 (submitted: March 5, 2013)
menstrual pattern and bleeding scores [ Time Frame: 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 compaired with each other at 3-6-12 months follow up.
 
Descriptive Information
Brief Title  ICMJE Comparison of Levonorgestrel Intrauterine System, Copper T Intrauterine Device and Oral Contraceptives on Life Quality
Official Title  ICMJE Comparison of Levonorgestrel Intrauterine System, Copper T Intrauterine Device and Oral Contraceptives on Life Quality
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Contraceptive Methods Comparison
Intervention  ICMJE
  • 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 Name: Miirena
Study Arms  ICMJE
  • Experimental: Levonorgestrel releasing intrauterine device, contraception
    LNG-IUS - Mirena ®,20μgr, once intrauterine insertion per 5 year, 1 year
    Interventions:
    • Drug: YASMIN® (Drospirenone/Ethinyl Estradiol)
    • Device: The Copper-T is an intrauterine device (IUD)
    • Device: levonorgestrel-releasing system
  • Experimental: YASMIN® (Drospirenone/Ethinyl Estradiol), contraception
    oral, once a day, 1 year
    Interventions:
    • Drug: YASMIN® (Drospirenone/Ethinyl Estradiol)
    • Device: The Copper-T is an intrauterine device (IUD)
    • Device: levonorgestrel-releasing system
  • Experimental: Copper T 380 A , contraception
    intrauterine device, once per 10 year, 1 year period
    Interventions:
    • Drug: YASMIN® (Drospirenone/Ethinyl Estradiol)
    • Device: The Copper-T is an intrauterine device (IUD)
    • Device: levonorgestrel-releasing system
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 5, 2013)
5
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01805817
Other Study ID Numbers  ICMJE cuzuncakmak1907
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cihangir Uzunçakmak, Istanbul Training and Research Hospital
Study Sponsor  ICMJE Istanbul Training and Research Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Istanbul Training and Research Hospital
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP