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).

Phase 4

Completed

• Conditions: Contraception
• Interventions: Drug: Levonorgestrel (13,5 mg) intrauterine device; Device: Cooper (380mm2) intrauterine device

• Registration Number: NCT02957292
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-01
• Study First Submitted: 2016-11-04
• Study First Submitted QC: 2016-11-04
• Study First Posted: 2016-11-06
• Primary Completion: 2020-09-15
• Study Completion: 2020-09-15
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-22
• Last Update Posted: 2021-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 108

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Levonorgestrel IUD	Levonorgestrel (13,5 mg) intrauterine device	13,5 mg Levonorgestrel intrauterine device
Copper IUD	Cooper (380mm2) intrauterine device	Copper (380mm2) intrauterine device

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain