Contraceptive Methods ComparisonPhase 4NCT01805817

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

A Phase 4 study testing YASMIN® (Drospirenone/Ethinyl Estradiol), The Copper-T is an intrauterine device (IUD) and levonorgestrel-releasing system in people with Contraceptive Methods Comparison, run by Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for: Contraceptive Methods Comparison
What is being tested?: YASMIN® (Drospirenone/Ethinyl Estradiol), The Copper-T is an intrauterine device (IUD) and levonorgestrel-releasing system
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 1 siteTurkey (Türkiye)
Study dates: Dec 2012to Dec 2013
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

women who desire contraception

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Istanbul Training and Research Hospital
Istanbul, 34098

Other trials in Turkey (Türkiye)

About this study

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.

Conditions: Contraceptive Methods Comparison
Being tested: YASMIN® (Drospirenone/Ethinyl Estradiol), The Copper-T is an intrauterine device (IUD), levonorgestrel-releasing system
Keywords: lipid profile, bleeding scores, menstrual pattern, beneficial, side effects, changes in a year period

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

YASMIN® (Drospirenone/Ethinyl Estradiol)Drug
oral contraceptive pills
The Copper-T is an intrauterine device (IUD)Device
intrauterine device for contraception
levonorgestrel-releasing systemDevice
Also called Miirena
intrauterine device

Study groups in NCT01805817
Study group	Role	What they receive
Levonorgestrel releasing intrauterine device, contraception	Experimental	LNG-IUS - Mirena ®,20μgr, once intrauterine insertion per 5 year, 1 year Receives: Drug: YASMIN® (Drospirenone/Ethinyl Estradiol); Device: The Copper-T is an intrauterine device (IUD); Device: levonorgestrel-releasing system
YASMIN® (Drospirenone/Ethinyl Estradiol), contraception	Experimental	oral, once a day, 1 year Receives: Drug: YASMIN® (Drospirenone/Ethinyl Estradiol); Device: The Copper-T is an intrauterine device (IUD); Device: levonorgestrel-releasing system
Copper T 380 A , contraception	Experimental	intrauterine device, once per 10 year, 1 year period Receives: Drug: YASMIN® (Drospirenone/Ethinyl Estradiol); Device: The Copper-T is an intrauterine device (IUD); Device: levonorgestrel-releasing system

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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 (1)

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.
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2012Dec 2013

First posted6 Mar 2013 (estimated)
Study startDec 2012
Primary completionDec 2013 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Contraceptive Methods ComparisonStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01805817
Sponsor's protocol ID: cuzuncakmak1907
Status last verified: Aug 2020
First submitted: 15 Feb 2013
Last updated: 13 Aug 2020
Results posted: No
Data monitoring committee: Yes

Publications

Haliloglu B, Celik A, Ilter E, Bozkurt S, Ozekici U. Comparison of uterine artery blood flow with levonorgestrel intrauterine system and copper intrauterine device. Contraception. 2011 Jun;83(6):578-81. doi: 10.1016/j.contraception.2010.09.001. Epub 2010 Oct 18.
PubMed 21570557
Sayed GH, Zakherah MS, El-Nashar SA, Shaaban MM. A randomized clinical trial of a levonorgestrel-releasing intrauterine system and a low-dose combined oral contraceptive for fibroid-related menorrhagia. Int J Gynaecol Obstet. 2011 Feb;112(2):126-30. doi: 10.1016/j.ijgo.2010.08.009. Epub 2010 Nov 19.
PubMed 21092958
Mansour D, Gemzell-Danielsson K, Inki P, Jensen JT. Fertility after discontinuation of contraception: a comprehensive review of the literature. Contraception. 2011 Nov;84(5):465-77. doi: 10.1016/j.contraception.2011.04.002. Epub 2011 Jun 8.
PubMed 22018120

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 4
The Effectiveness of Topical Prilocaine-Lidocaine Cream Plus Acetaminophen and Naproxen Compared to Lidocaine Injection Plus Acetaminophen and Naproxen to Manage Pain During IntraUterine Device Insertion
Pain During Intrauterine Device Insertion
Active, not recruitingPhase 4
LF111 or Drospirenone Chew vs Non-hormonal Contraceptive Methods on Bone Mineral Density in Adolescent and Adult Women
Change in Bone Mineral Density, Bone Loss
Active, not recruiting
Levonorgestrel Intrauterine System Effects on Hemoglobin and Serum Ferritin Among Anemic Women in Kenya
Anemia
Not yet recruiting
Empathy Through Pain Control: Buffered Compared to Unbuffered 1% Lidocaine During IUD Placement
Contraception, Pain, Acute
Not yet recruiting
Telemedicine for Contraceptive Counselling- An Open Randomized Controlled Trial
Unintended Pregnancy Prevention

All Contraceptive Methods Comparison trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Levonorgestrel Intrauterine System, Copper T Intrauterine Device and Oral Contraceptives on Life Quality
ClinicalTrials.gov ID: NCT01805817
Acronym / sponsor ID: cuzuncakmak1907
Conditions: Contraceptive Methods Comparison
Keywords: lipid profile, bleeding scores, menstrual pattern, beneficial, side effects, changes in a year period
Phase: Phase 4
Study type: Interventional
Recruitment status: Withdrawn
Enrolment: 0 participants (actual)
Lead sponsor: Istanbul Training and Research HospitalOther government
Study start: Dec 2012
Primary completion: Dec 2013 (estimated)
First posted: 6 Mar 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Levonorgestrel releasing intrauterine device, contraception	Experimental	Drug: YASMIN® (Drospirenone/Ethinyl Estradiol), Device: The Copper-T is an intrauterine device (IUD), Device: levonorgestrel-releasing systemLNG-IUS - Mirena ®,20μgr, once intrauterine insertion per 5 year, 1 year
YASMIN® (Drospirenone/Ethinyl Estradiol), contraception	Experimental	Drug: YASMIN® (Drospirenone/Ethinyl Estradiol), Device: The Copper-T is an intrauterine device (IUD), Device: levonorgestrel-releasing systemoral, once a day, 1 year
Copper T 380 A , contraception	Experimental	Drug: YASMIN® (Drospirenone/Ethinyl Estradiol), Device: The Copper-T is an intrauterine device (IUD), Device: levonorgestrel-releasing systemintrauterine device, once per 10 year, 1 year period

Who may qualify

Ages: 18 to 50 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

women who desire contraception

Key exclusion criteria (1 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
YASMIN® (Drospirenone/Ethinyl Estradiol)oral contraceptive pills	Drug	Copper T 380 A , contraception, Levonorgestrel releasing intrauterine device, contraception, YASMIN® (Drospirenone/Ethinyl Estradiol), contraception
The Copper-T is an intrauterine device (IUD)intrauterine device for contraception	Device	Copper T 380 A , contraception, Levonorgestrel releasing intrauterine device, contraception, YASMIN® (Drospirenone/Ethinyl Estradiol), contraception
levonorgestrel-releasing systemAlso: Miirenaintrauterine device	Device	Copper T 380 A , contraception, Levonorgestrel releasing intrauterine device, contraception, YASMIN® (Drospirenone/Ethinyl Estradiol), contraception

Primary outcome

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.

1 secondary outcome

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

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
Background: PubMed 21570557Haliloglu B, Celik A, Ilter E, Bozkurt S, Ozekici U. Comparison of uterine artery blood flow with levonorgestrel intrauterine system and copper intrauterine device. Contraception. 2011 Jun;83(6):578-81. doi: 10.1016/j.contraception.2010.09.001. Epub 2010 Oct 18.
Background: PubMed 21092958Sayed GH, Zakherah MS, El-Nashar SA, Shaaban MM. A randomized clinical trial of a levonorgestrel-releasing intrauterine system and a low-dose combined oral contraceptive for fibroid-related menorrhagia. Int J Gynaecol Obstet. 2011 Feb;112(2):126-30. doi: 10.1016/j.ijgo.2010.08.009. Epub 2010 Nov 19.
Background: PubMed 22018120Mansour D, Gemzell-Danielsson K, Inki P, Jensen JT. Fertility after discontinuation of contraception: a comprehensive review of the literature. Contraception. 2011 Nov;84(5):465-77. doi: 10.1016/j.contraception.2011.04.002. Epub 2011 Jun 8.
database for medical publicationLink provided by the sponsor.

Related trials for Contraceptive Methods Comparison

Not yet recruitingPhase 4
The Effectiveness of Topical Prilocaine-Lidocaine Cream Plus Acetaminophen and Naproxen Compared to Lidocaine Injection Plus Acetaminophen and Naproxen to Manage Pain During IntraUterine Device Insertion
Pain During Intrauterine Device Insertion
Active, not recruitingPhase 4
LF111 or Drospirenone Chew vs Non-hormonal Contraceptive Methods on Bone Mineral Density in Adolescent and Adult Women
Change in Bone Mineral Density, Bone Loss
Active, not recruiting
Levonorgestrel Intrauterine System Effects on Hemoglobin and Serum Ferritin Among Anemic Women in Kenya
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Empathy Through Pain Control: Buffered Compared to Unbuffered 1% Lidocaine During IUD Placement
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Telemedicine for Contraceptive Counselling- An Open Randomized Controlled Trial
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01805817, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2020.