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).

NCT02957292 | Completed Phase 4

• 1 other identifier: IIBSP-DIU-2015-85
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Contraception

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Levonorgestrel IUD

EXPERIMENTAL

13,5 mg Levonorgestrel intrauterine device

Drug: Levonorgestrel (13,5 mg) intrauterine device

Copper IUD

ACTIVE COMPARATOR

Copper (380mm2) intrauterine device

Device: Cooper (380mm2) intrauterine device

Interventions

Levonorgestrel (13,5 mg) intrauterine device DRUG

Levonorgestrel IUD

Cooper (380mm2) intrauterine device DEVICE

Copper IUD

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead
• Bayer: collaborator

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

MeSH Terms

Interventions

Levonorgestrel; Intrauterine Devices

Intervention Hierarchy (Ancestors)

Norgestrel; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Contraceptive Devices, Female; Contraceptive Devices; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2016
• First Posted: November 7, 2016
• Study Start: June 1, 2016
• Primary Completion: September 15, 2020
• Study Completion: September 15, 2020
• Last Updated: October 28, 2021

Record last verified: 2021-10

Locations

ES (1)