ContraceptionPhase 4COLIBRINCT02957292
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).
A Phase 4 study testing Levonorgestrel (13,5 mg) intrauterine device and Cooper (380mm2) intrauterine device in people with Contraception, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Contraception
- What is being tested?
- Levonorgestrel (13,5 mg) intrauterine device and Cooper (380mm2) intrauterine device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2016to 15 Sep 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial to Compare the Menstrual Bleeding Profile Among Copper and 13,5mg Levonorgestrel-releasing IUD Users.
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.
Read more
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
- Being tested
- Levonorgestrel (13,5 mg) intrauterine device, Cooper (380mm2) intrauterine device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levonorgestrel (13,5 mg) intrauterine deviceDrug
Cooper (380mm2) intrauterine deviceDevice
| Study group | Role | What they receive |
|---|---|---|
| Levonorgestrel IUD | Experimental | 13,5 mg Levonorgestrel intrauterine device Receives: Drug: Levonorgestrel (13,5 mg) intrauterine device |
| Copper IUD | Active comparator | Copper (380mm2) intrauterine device Receives: Device: Cooper (380mm2) intrauterine device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of menstrual bleeding days
Daily recorded during 90 days treatment period
Measured: 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
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2016 (estimated)
- Study start1 Jun 2016
- Primary completion15 Sep 2020
- Study completion15 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02957292
- Sponsor's protocol ID
- IIBSP-DIU-2015-85
- Acronym
- COLIBRI
- Status last verified
- Oct 2021
- First submitted
- 4 Nov 2016
- Last updated
- 28 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Compare the Menstrual Bleeding Profile Among Copper and 13,5mg Levonorgestrel-releasing IUD Users.
- ClinicalTrials.gov ID
- NCT02957292
- Acronym / sponsor ID
- COLIBRI / IIBSP-DIU-2015-85
- Conditions
- Contraception
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 15 Sep 2020 (actual)
- Study completion
- 15 Sep 2020 (actual)
- First posted
- 7 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levonorgestrel IUD | Experimental | Drug: Levonorgestrel (13,5 mg) intrauterine device13,5 mg Levonorgestrel intrauterine device |
| Copper IUD | Active comparator | Device: Cooper (380mm2) intrauterine deviceCopper (380mm2) intrauterine device |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levonorgestrel (13,5 mg) intrauterine device | Drug | Levonorgestrel IUD |
| Cooper (380mm2) intrauterine device | Device | Copper IUD |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levonorgestrel (13,5 mg) intrauterine device and Cooper (380mm2) intrauterine device in people with Contraception, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of menstrual bleeding days (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2021.