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

NCT ID: NCT01805817

Last Updated: 2020-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Brief Summary

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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

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Conditions

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Contraceptive Methods Comparison

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Levonorgestrel releasing intrauterine device, contraception

LNG-IUS - Mirena ®,20μgr, once intrauterine insertion per 5 year, 1 year

Group Type EXPERIMENTAL

YASMIN® (Drospirenone/Ethinyl Estradiol)

Intervention Type DRUG

oral contraceptive pills

The Copper-T is an intrauterine device (IUD)

Intervention Type DEVICE

intrauterine device for contraception

levonorgestrel-releasing system

Intervention Type DEVICE

intrauterine device

YASMIN® (Drospirenone/Ethinyl Estradiol), contraception

oral, once a day, 1 year

Group Type EXPERIMENTAL

YASMIN® (Drospirenone/Ethinyl Estradiol)

Intervention Type DRUG

oral contraceptive pills

The Copper-T is an intrauterine device (IUD)

Intervention Type DEVICE

intrauterine device for contraception

levonorgestrel-releasing system

Intervention Type DEVICE

intrauterine device

Copper T 380 A , contraception

intrauterine device, once per 10 year, 1 year period

Group Type EXPERIMENTAL

YASMIN® (Drospirenone/Ethinyl Estradiol)

Intervention Type DRUG

oral contraceptive pills

The Copper-T is an intrauterine device (IUD)

Intervention Type DEVICE

intrauterine device for contraception

levonorgestrel-releasing system

Intervention Type DEVICE

intrauterine device

Interventions

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YASMIN® (Drospirenone/Ethinyl Estradiol)

oral contraceptive pills

Intervention Type DRUG

The Copper-T is an intrauterine device (IUD)

intrauterine device for contraception

Intervention Type DEVICE

levonorgestrel-releasing system

intrauterine device

Intervention Type DEVICE

Other Intervention Names

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Miirena

Eligibility Criteria

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Inclusion Criteria

* women who desire contraception
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Istanbul Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Cihangir Uzunçakmak

Medical Doctor, OB/GYN

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Istanbul Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 21570557 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21092958 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22018120 (View on PubMed)

Related Links

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Other Identifiers

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cuzuncakmak1907

Identifier Type: -

Identifier Source: org_study_id

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