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
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|
|Intervention Model:||Parallel Assignment|
|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|
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
- Number of menstrual bleeding days [ Time Frame: 90 days ]Daily recorded during 90 days treatment period
- 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
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
|Contact: Josep Perelló, MDfirstname.lastname@example.org|
|Hospital de la Santa Creu i Sant Pau||Recruiting|
|Barcelona, Spain, 08025|
|Contact: Josep Perelló, MD +34935537041 email@example.com|