Hormonal Intrauterine ContraceptionCORANCT04785950
The Aim of This Study is to Estimate the Discontinuation Rate of Low-dose Levonorgestrel-releasing Intrauterine System Due to Self-reported Unacceptable Menstrual Bleeding Pattern in Spanish Women Who Are Using it for the First Time How Intrauterine System for Long Acting Contraception
An observational study of Hormonal Intrauterine Contraception, run by Bayer at 1 site in Spain.
Trial summary
Researchers are looking for better ways to help women prevent pregnancy. Every month, a woman's body prepares for pregnancy in a process called the menstrual cycle. When pregnancy does not happen, menstruation occurs. During menstruation, women lose blood and tissue from inside the womb. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Hormonal Intrauterine Contraception
- What is being tested?
- Low-dose levonorgestrel intrauterine systems (LNG-IUS)
- How many people
- 316 participants
- Where
- 1 siteSpain
- Study dates
- 21 Feb 2021to 4 May 2023
- Phase
- Observational
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Study population: Young adult women from Spain
Who may be able to join
- Women aged 18 to 35 years.
- Women who have freely chosen a low-dose LNG-IUS for the first time as contraceptive method and it has been successfully inserted previously to invite the woman to participate in the study.
- Women capable of reading and writing.
- Women who signed the informed consent form.
- Women who are not participating in an investigational program with interventions outside of routine clinical practice.
- Women without a mental illness and able to make decisions and follow instructions.
- Women without contraindications to a low-dose LNG-IUS according to the local marketing authorization.
- Women without concomitant medications that may lead to changes in the bleeding pattern (e.g. antiplatelet and/or anticoagulants).
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Observational, Prospective, Multicenter Study to Assess the Continuation Rates and User Acceptability of Bleeding Profile in First-time Users of Low-dose LNG-IUS
Researchers are looking for better ways to help women prevent pregnancy. Every month, a woman's body prepares for pregnancy in a process called the menstrual cycle. When pregnancy does not happen, menstruation occurs. During menstruation, women lose blood and tissue from inside the womb. This bleeding can last for about 2 to 7 days.
Hormonal intrauterine contraception aims to help women prevent pregnancy by stopping the process of the menstrual cycle. Intrauterine means that the contraception is in the form of a device that is inserted into a woman's womb by her doctor. The device then releases the contraception into the womb.
Read more
Researchers have found that when women use hormonal contraception, the disruption to the menstrual cycle can cause changes to how often and for how long women will bleed. So, the researchers in this study want to learn more about the menstrual bleeding patterns of women in Spain who are using hormonal intrauterine contraception for the first time. In other words, In particular for the LNG-IUSs, irregular bleeding due to the local effect of levonorgestrel on the endometrium is common, particularly during the first 3 months of use, and it is of interest to know if this is a major reason why Spanish women discontinue this very effective method and what other factors may be associated with discontinuation. The researchers will then use this information to estimate how many women choose to stop using the contraception. The participants will be able to enroll in this study after requesting hormonal intrauterine contraception from their doctor. They will be women between the ages of 18 and 35 who have never used hormonal intrauterine contraception before.
The participants will visit the study site 3 times. On the first visit, they will receive the hormonal intrauterine contraception. The doctors will also check their health to make sure they can join the study. The participants will visit the study site again 4-12 weeks later, and one last time after 1 year of having the hormonal intrauterine contraception. During these visits, the doctors will ask the participants questions about any medical problems they have and if they want to continue using the contraception. Throughout the study, the participants will use a mobile app to track information about their menstrual bleeding and how they feel about it.
- Conditions
- Hormonal Intrauterine Contraception
- Being tested
- Low-dose levonorgestrel intrauterine systems (LNG-IUS)
- Keywords
- Intrauterine system (IUS), Levonorgestrel (LNG), Menstrual bleeding, Discontinuation of intrauterine systems
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose levonorgestrel intrauterine systems (LNG-IUS)Drug
Any low-dose intrauterine system (IUS) marketed in Spain
| Study group | Role | What they receive |
|---|---|---|
| Women with IUS | Women aged 18 to 35 years from Spain who chose to use any low-dose LNG-IUS marketed in Spain for the first time during routine clinical practice Receives: Drug: Low-dose levonorgestrel intrauterine systems (LNG-IUS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of women who discontinue the use of low-dose LNG-IUS due to the unacceptability of their menstrual bleeding pattern
Measured: Up to 12 months
Secondary outcomes (16)
Percentage of women who discontinued lowdose LNG-IUS due to other reasons
Measured: At final visit (up to 12 months)
Women's perception of the amount of information received during preinsertion counselling about the potential changes in menstrual bleeding pattern after lowdose LNG-IUS insertion
Did you received information during pre-insertion counselling about the potential changes in menstrual bleeding pattern after low-dose LNG-IUS insertion?
- A lot
- Quite a lot
- A moderate amount
- Relative little
- Very little
Measured: At final visit (up to 12 months)
Potential correlation of women's perception on pre-insertion counselling with overall satisfaction with menstrual bleeding pattern
Measured: At final visit (up to 12 months)
Usage of the mobile apps to support menstrual tracking (regularly, sporadically, never)
Measured: At initial visit, follow-up and final visit (up to 12 months)
Overall satisfaction with the menstrual app (very satisfied; satisfied; neither satisfied nor dissatisfied; dissatisfied; very dissatisfied)
Measured: At initial visit, follow-up and final visit (up to 12 months)
Correlation between the use of a menstrual app and discontinuation
Measured: At initial visit, follow-up and final visit (up to 12 months)
Correlation between the use of a menstrual app and overall satisfaction with menstrual bleeding pattern
Measured: At initial visit, follow-up and final visit (up to 12 months)
Size of uterine cavity
Measured: At initial visit (Day 0)
Menstrual bleeding pattern with 8 parameters
8 Parameters:
- Presence/absence of menstrual bleeding
- Frequency: frequent: <24 days; normal: 24-38 days; infrequent: >38 days
- Regularity of withdrawal bleeding: regular, one bleeding episode per cycle; irregular, all those cycles that are not regular
- Duration: long: >8 days; normal: 4-8 days; short: <4 days
- Quantity: 10 cm visual analogue scale (VAS) (on the left "absence of bleeding"; on the right "worst imaginable bleeding")
- Menstrual pain: 10 cm VAS (on the left "no pain"; on the right "worst imaginable pain"
- Presence/absence of intermenstrual vaginal bleeding or spotting: yes; no
- Interference in daily activities: not at all; mildly; moderately; severely
Measured: Up to 12 months
Change of menstrual bleeding pattern with 8 parameters between baseline and 4 to12 weeks / final visit
8 Parameters:
- Presence/absence of menstrual bleeding
- Frequency: frequent: <24 days; normal: 24-38 days; infrequent: >38 days
- Regularity of withdrawal bleeding: regular, one bleeding episode per cycle; irregular, all those cycles that are not regular
- Duration: long: >8 days; normal: 4-8 days; short: <4 days
- Quantity: 10 cm visual analogue scale (VAS) (on the left "absence of bleeding"; on the right "worst imaginable bleeding")
- Menstrual pain: 10 cm VAS (on the left "no pain"; on the right "worst imaginable pain"
- Presence/absence of intermenstrual vaginal bleeding or spotting: yes; no
- Interference in daily activities: not at all; mildly; moderately; severely
Measured: Up to 12 months
Correlation between uterine cavity size and menstrual bleeding pattern
Measured: Up to 12 months
Overall satisfaction with menstrual bleeding pattern assessed on a 5-point Likert scale (Very satisfied; Satisfied; Neither satisfied nor dissatisfied; Dissatisfied)
Measured: At baseline, at the follow-up visit and at the final visit (up to 12 months)
Change in satisfaction with menstrual bleeding pattern assessed on a 5-point Likert scale (Very satisfied; Satisfied; Neither satisfied nor dissatisfied; Dissatisfied) between baseline and 4-12 weeks / final visit
Measured: At baseline, at the follow-up visit and at the final visit (up to 12 months)
Correlation between overall satisfaction with menstrual bleeding and the menstrual bleeding pattern
Measured: At baseline, at the follow-up visit and at the final visit (up to 12 months)
Percentage of women that would recommend the use of low-dose LNG-IUS to a friend
Measured: At final visit (up to 12 months)
Days up to discontinuation day
Measured: at the follow-up visit and at the final visit (up to 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start21 Feb 2021
- Primary completion12 Jan 2023
- Study completion4 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hormonal Intrauterine ContraceptionStudies of the same condition, open and under way.
- More trials run by BayerThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 316 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04785950
- Sponsor's protocol ID
- 21279
- Acronym
- CORA
- Status last verified
- Jun 2023
- First submitted
- 4 Feb 2021
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational, Prospective, Multicenter Study to Assess the Continuation Rates and User Acceptability of Bleeding Profile in First-time Users of Low-dose LNG-IUS
- ClinicalTrials.gov ID
- NCT04785950
- Acronym / sponsor ID
- CORA / 21279
- Conditions
- Hormonal Intrauterine Contraception
- Keywords
- Intrauterine system (IUS), Levonorgestrel (LNG), Menstrual bleeding, Discontinuation of intrauterine systems
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 316 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 21 Feb 2021 (actual)
- Primary completion
- 12 Jan 2023 (actual)
- Study completion
- 4 May 2023 (actual)
- First posted
- 8 Mar 2021 (actual)
- 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.
Researchers are looking for better ways to help women prevent pregnancy. Every month, a woman's body prepares for pregnancy in a process called the menstrual cycle. When pregnancy does not happen, menstruation occurs. During menstruation, women lose blood and tissue from inside the womb. This bleeding can last for about 2 to 7 days.
Hormonal intrauterine contraception aims to help women prevent pregnancy by stopping the process of the menstrual cycle. Intrauterine means that the contraception is in the form of a device that is inserted into a woman's womb by her doctor. The device then releases the contraception into the womb.
Researchers have found that when women use hormonal contraception, the disruption to the menstrual cycle can cause changes to how often and for how long women will bleed. So, the researchers in this study want to learn more about the menstrual bleeding patterns of women in Spain who are using hormonal intrauterine contraception for the first time. In other words, In particular for the LNG-IUSs, irregular bleeding due to the local effect of levonorgestrel on the endometrium is common, particularly during the first 3 months of use, and it is of interest to know if this is a major reason why Spanish women discontinue this very effective method and what other factors may be associated with discontinuation. The researchers will then use this information to estimate how many women choose to stop using the contraception. The participants will be able to enroll in this study after requesting hormonal intrauterine contraception from their doctor. They will be women between the ages of 18 and 35 who have never used hormonal intrauterine contraception before.
The participants will visit the study site 3 times. On the first visit, they will receive the hormonal intrauterine contraception. The doctors will also check their health to make sure they can join the study. The participants will visit the study site again 4-12 weeks later, and one last time after 1 year of having the hormonal intrauterine contraception. During these visits, the doctors will ask the participants questions about any medical problems they have and if they want to continue using the contraception. Throughout the study, the participants will use a mobile app to track information about their menstrual bleeding and how they feel about it.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with IUS | – | Drug: Low-dose levonorgestrel intrauterine systems (LNG-IUS)Women aged 18 to 35 years from Spain who chose to use any low-dose LNG-IUS marketed in Spain for the first time during routine clinical practice |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Young adult women from Spain
Key inclusion criteria (8 listed)
- Women aged 18 to 35 years.
- Women who have freely chosen a low-dose LNG-IUS for the first time as contraceptive method and it has been successfully inserted previously to invite the woman to participate in the study.
- Women capable of reading and writing.
- Women who signed the informed consent form.
- Women who are not participating in an investigational program with interventions outside of routine clinical practice.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Low-dose levonorgestrel intrauterine systems (LNG-IUS)Any low-dose intrauterine system (IUS) marketed in Spain | Drug | Women with IUS |
Primary outcome
Percentage of women who discontinue the use of low-dose LNG-IUS due to the unacceptability of their menstrual bleeding pattern
Time frame: Up to 12 months
16 secondary outcomes
Percentage of women who discontinued lowdose LNG-IUS due to other reasons
Time frame: At final visit (up to 12 months)
Women's perception of the amount of information received during preinsertion counselling about the potential changes in menstrual bleeding pattern after lowdose LNG-IUS insertion
Time frame: At final visit (up to 12 months)
Potential correlation of women's perception on pre-insertion counselling with overall satisfaction with menstrual bleeding pattern
Time frame: At final visit (up to 12 months)
Usage of the mobile apps to support menstrual tracking (regularly, sporadically, never)
Time frame: At initial visit, follow-up and final visit (up to 12 months)
Overall satisfaction with the menstrual app (very satisfied; satisfied; neither satisfied nor dissatisfied; dissatisfied; very dissatisfied)
Time frame: At initial visit, follow-up and final visit (up to 12 months)
Correlation between the use of a menstrual app and discontinuation
Time frame: At initial visit, follow-up and final visit (up to 12 months)
Correlation between the use of a menstrual app and overall satisfaction with menstrual bleeding pattern
Time frame: At initial visit, follow-up and final visit (up to 12 months)
Size of uterine cavity
Time frame: At initial visit (Day 0)
Menstrual bleeding pattern with 8 parameters
Time frame: Up to 12 months
Change of menstrual bleeding pattern with 8 parameters between baseline and 4 to12 weeks / final visit
Time frame: Up to 12 months
Correlation between uterine cavity size and menstrual bleeding pattern
Time frame: Up to 12 months
Overall satisfaction with menstrual bleeding pattern assessed on a 5-point Likert scale (Very satisfied; Satisfied; Neither satisfied nor dissatisfied; Dissatisfied)
Time frame: At baseline, at the follow-up visit and at the final visit (up to 12 months)
Change in satisfaction with menstrual bleeding pattern assessed on a 5-point Likert scale (Very satisfied; Satisfied; Neither satisfied nor dissatisfied; Dissatisfied) between baseline and 4-12 weeks / final visit
Time frame: At baseline, at the follow-up visit and at the final visit (up to 12 months)
Correlation between overall satisfaction with menstrual bleeding and the menstrual bleeding pattern
Time frame: At baseline, at the follow-up visit and at the final visit (up to 12 months)
Percentage of women that would recommend the use of low-dose LNG-IUS to a friend
Time frame: At final visit (up to 12 months)
Days up to discontinuation day
Time frame: at the follow-up visit and at the final visit (up to 12 months)
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 15 Jun 2023.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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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?
An observational study of Hormonal Intrauterine Contraception, run by Bayer 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 8 inclusion and 1 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 15 Jun 2023. 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.
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?
Percentage of women who discontinue the use of low-dose LNG-IUS due to the unacceptability of their menstrual bleeding pattern (time frame: Up to 12 months). 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 15 Jun 2023.