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).
NCT ID: NCT02957292
Last Updated: 2021-10-28
Study Results
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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COMPLETED
PHASE4
108 participants
INTERVENTIONAL
2016-06-01
2020-09-15
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Levonorgestrel IUD
13,5 mg Levonorgestrel intrauterine device
Levonorgestrel (13,5 mg) intrauterine device
Copper IUD
Copper (380mm2) intrauterine device
Cooper (380mm2) intrauterine device
Interventions
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Levonorgestrel (13,5 mg) intrauterine device
Cooper (380mm2) intrauterine device
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
45 Years
FEMALE
No
Sponsors
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Bayer
INDUSTRY
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
OTHER
Responsible Party
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Locations
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Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Countries
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Other Identifiers
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IIBSP-DIU-2015-85
Identifier Type: -
Identifier Source: org_study_id