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).

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (Other)

Overall Status

Completed

CT.gov ID

NCT02957292

Collaborator

Bayer (Industry)

108

Enrollment

Location

Arms

51.5

Actual Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

Actual Enrollment :

108 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.

Actual Study Start Date :

Jun 1, 2016

Actual Primary Completion Date :

Sep 15, 2020

Actual Study Completion Date :

Sep 15, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Number of menstrual bleeding days [90 days]
Daily recorded during 90 days treatment period
Amount of Menstrual bleeding [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital de la Santa Creu i Sant Pau	Barcelona		Spain	08025

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

ClinicalTrials.gov Identifier:

NCT02957292

Other Study ID Numbers:

IIBSP-DIU-2015-85

First Posted:

Nov 6, 2016

Last Update Posted:

Oct 28, 2021

Last Verified:

Oct 1, 2021

Additional relevant MeSH terms:

Hemorrhage

Levonorgestrel

Study Results

No Results Posted as of Oct 28, 2021