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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Istanbul Training and Research Hospital
Sponsor:
Information provided by (Responsible Party):
Cihangir Uzunçakmak, Istanbul Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT01805817
First received: February 15, 2013
Last updated: March 6, 2013
Last verified: March 2013
  Purpose

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 Intervention Phase
Contraceptive Methods Comparison
Drug: YASMIN® (Drospirenone/Ethinyl Estradiol)
Device: The Copper-T is an intrauterine device (IUD)
Device: levonorgestrel-releasing system
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Levonorgestrel Intrauterine System, Copper T Intrauterine Device and Oral Contraceptives on Life Quality

Resource links provided by NLM:


Further study details as provided by Istanbul Training and Research Hospital:

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) [ 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 ] [ Designated as safety issue: Yes ]
    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) [ 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 ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: Change from Baseline pictorial blood scoring system scores at 3 months, Baseline to 6 months, Baseline to 12 months will be assessed ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 5
Study Start Date: December 2012
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: Miirena

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01805817

Contacts
Contact: Cihangir Uzunçakmak, M.D. 0090 505 4505808 cuzuncakmak@gmail.com

Locations
Turkey
Istanbul Training and Research Hospital Recruiting
Istanbul, Turkey, 34098
Contact: Cihangir Uzunçakmak, M.D.    0090 505 4505808    cuzuncakmak@gmail.com   
Principal Investigator: Cihangir Uzuncakmak, M.D.         
Sponsors and Collaborators
Istanbul Training and Research Hospital
  More Information

Additional Information:
Publications:
Responsible Party: Cihangir Uzunçakmak, Medical Doctor, OB/GYN, Istanbul Training and Research Hospital
ClinicalTrials.gov Identifier: NCT01805817     History of Changes
Other Study ID Numbers: cuzuncakmak1907
Study First Received: February 15, 2013
Last Updated: March 6, 2013
Health Authority: TURKEY :İstanbul Training and Research Hospital Obstetrics and Gynecology Admiministration
United States: Food and Drug Administration

Keywords provided by Istanbul Training and Research Hospital:
lipid profile
bleeding scores
menstrual pattern
beneficial
side effects
changes in a year period

Additional relevant MeSH terms:
Estradiol
Ethinyl Estradiol
Drospirenone
Contraceptive Agents
Levonorgestrel
Contraceptives, Oral
Drospirenone and ethinyl estradiol combination
Copper
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Trace Elements
Micronutrients
Growth Substances
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 16, 2014