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).

Study Overview
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Brief Summary
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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.

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

Conditions
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Contraception

Intervention / Treatment
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* Drug: Levonorgestrel (13,5 mg) intrauterine device
* Device: Cooper (380mm2) intrauterine device


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Levonorgestrel IUD<br>13,5 mg Levonorgestrel intrauterine device | Drug: Levonorgestrel (13,5 mg) intrauterine device<br> <br> |
| Active Comparator: Copper IUD<br>Copper (380mm2) intrauterine device | Device: Cooper (380mm2) intrauterine device<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of menstrual bleeding days | Daily recorded during 90 days treatment period | 90 days | 
| Amount of Menstrual bleeding | 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 | 90 days |