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).

Contraception Clinical Trial

— COLIBRI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02957292
• Other study ID #: IIBSP-DIU-2015-85
• Status: Completed
• Phase: Phase 4
• Start date: June 1, 2016
• Est. completion date: September 15, 2020

Study information

• Verified date: October 2021
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: September 15, 2020
• Est. primary completion date: September 15, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Contraception
• Hemorrhage

Intervention

Drug:
• Levonorgestrel (13,5 mg) intrauterine device

Device:
• Cooper (380mm2) intrauterine device

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Bayer

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of menstrual bleeding days	Daily recorded during 90 days treatment period	90 days
Primary	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