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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). (COLIBRI)

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ClinicalTrials.gov Identifier: NCT02957292
Recruitment Status : Recruiting
First Posted : November 7, 2016
Last Update Posted : November 7, 2016
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Contraception Drug: Levonorgestrel (13,5 mg) intrauterine device Device: Cooper (380mm2) intrauterine device Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial to Compare the Menstrual Bleeding Profile Among Copper and 13,5mg Levonorgestrel-releasing IUD Users.
Study Start Date : June 2016
Estimated Primary Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Levonorgestrel IUD
13,5 mg Levonorgestrel intrauterine device
Drug: Levonorgestrel (13,5 mg) intrauterine device
Active Comparator: Copper IUD
Copper (380mm2) intrauterine device
Device: Cooper (380mm2) intrauterine device



Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02957292


Contacts
Contact: Josep Perelló, MD +34935537041 jperello@santpau.cat

Locations
Spain
Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 08025
Contact: Josep Perelló, MD    +34935537041    estudiocolibri2016@gmail.com   
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Bayer

Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT02957292     History of Changes
Other Study ID Numbers: IIBSP-DIU-2015-85
First Posted: November 7, 2016    Key Record Dates
Last Update Posted: November 7, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Levonorgestrel
Copper
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Trace Elements
Micronutrients
Growth Substances