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

August 12, 2020 updated by: Cihangir Uzunçakmak, Istanbul Training and Research Hospital

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34098
        • Istanbul Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Change from Baseline pictorial blood scoring system scores at 3 months, Baseline to 6 months, Baseline to 12 months will be assessed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2012

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 15, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 6, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 13, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • cuzuncakmak1907

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