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

NCT01805817 | Withdrawn Phase 4 DMC

• 1 other identifier: cuzuncakmak1907
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Contraceptive Methods Comparison

Keywords

lipid profile; bleeding scores; menstrual pattern; beneficial; side effects; changes in a year period

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  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 Outcomes (1)

• menstrual pattern and bleeding scores(composite measurement)

  Change from Baseline pictorial blood scoring system scores at 3 months, Baseline to 6 months, Baseline to 12 months will be assessed

Study Arms (3)

Levonorgestrel releasing intrauterine device, contraception

EXPERIMENTAL

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

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

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

Drug: YASMIN® (Drospirenone/Ethinyl Estradiol); Device: The Copper-T is an intrauterine device (IUD); Device: levonorgestrel-releasing system

Interventions

YASMIN® (Drospirenone/Ethinyl Estradiol) DRUG

oral contraceptive pills

Copper T 380 A , contraception; Levonorgestrel releasing intrauterine device, contraception; YASMIN® (Drospirenone/Ethinyl Estradiol), contraception

The Copper-T is an intrauterine device (IUD) DEVICE

intrauterine device for contraception

Copper T 380 A , contraception; Levonorgestrel releasing intrauterine device, contraception; YASMIN® (Drospirenone/Ethinyl Estradiol), contraception

levonorgestrel-releasing system DEVICE

intrauterine device

Also known as: Miirena

Copper T 380 A , contraception; Levonorgestrel releasing intrauterine device, contraception; YASMIN® (Drospirenone/Ethinyl Estradiol), contraception

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• women who desire contraception

Sponsors & Collaborators

• Istanbul Training and Research Hospital: lead

Study Sites (1)

Istanbul Training and Research Hospital

Istanbul, 34098, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 21570557 BACKGROUND

• 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.

  PMID: 21092958 BACKGROUND

• 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.

  PMID: 22018120 BACKGROUND

Related Links

• database for medical publication

MeSH Terms

Interventions

drospirenone and ethinyl estradiol combination; drospirenone; Ethinyl Estradiol

Intervention Hierarchy (Ancestors)

Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, OB/GYN

Study Record Dates

• First Submitted: February 15, 2013
• First Posted: March 6, 2013
• Study Start: December 1, 2012
• Primary Completion: December 1, 2013
• Last Updated: August 13, 2020

Record last verified: 2020-08

Locations

TU (1)