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Completed

NCT Number: NCT02957292

A Study to Compare the Menstrual Bleeding Profile Among Jaydess® and Copper Intrauterine Device (IUD) Users. COLIBRI STUDY (Copper and Levonorgestrel IUD Barcelona Research Initiative).

The intrauterine device (IUD) is a long-term birth control method that has demonstrated high contraceptive efficacy and effectiveness due to its high compliance, adherence and persistence of use. The IUD has a global prevalence rate around 14% in women of reproductive age.

Side effects are the main reason for IUD use discontinuation. The most common reasons for copper IUD discontinuation are increased menstrual bleeding, irregular bleeding and dysmenorrhea, whereas in the case of 52mg Levonorgestrel IUD are irregular bleeding and amenorrhea.

In 2014, a new hormonal IUD containing13,5mg of Levonorgestrel was marketed in Spain. There are many studies comparing the two Levonorgestrel IUDs. However, there is any study comparing the IUD 13,5mg Levonorgestrel with classic copper IUDs.

The hypothesis of this trial is that Levonorgestrel (13,5mg) IUD users have a menstrual bleeding pattern with fewer days than Copper 380 mm2 IUD users.

This is a Phase IV, national single-center, randomized 1: 1, single-blind, comparative, parallel controled trial.

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Key information

Conditions

Contraception

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy female subject.
  • Parous or nulliparous women aged between 18 and 45 years who ask for an IUD as a contraceptive method.
  • History of regular cyclic menstrual periods ranged from 21 to 35 days with non-excessive menstrual blood loss.

Exclusion criteria

  • Absolute contraindications to IUD use, according to the World Health Organization Medical Eligibility Criteria.
  • Contraindications to use 13,5 LNG-IUD.
  • Anemia.
  • Use of short or long-acting preparations containing sex hormones within the 12 weeks before the IUD insertion.
  • Known bleeding irregularities.
  • Pregnancy or breast-feeding.

Treatment and study plan

Levonorgestrel (13,5 mg) intrauterine device

Drug

Cooper (380mm2) intrauterine device

Device

Primary outcomes

  1. Number of menstrual bleeding days

    Time frame: 90 days

    Daily recorded during 90 days treatment period

  2. Amount of Menstrual bleeding

    Time frame: 90 days

    Classified using a 5-item Likert-like scale from none to heavy, a pictorial blood loss assessment chart (PBAC), and ferritin and haemoglobin blood test determinations

Sponsors and collaborators

Lead sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Other

Collaborators

  • Bayer

Registry information

Official study title

A Randomized Controlled Trial to Compare the Menstrual Bleeding Profile Among Copper and 13,5mg Levonorgestrel-releasing IUD Users.

Acronym: COLIBRI

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Nov 7, 2016
Registry last updated
Oct 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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