ContraceptionBERTANCT03493295
Non-interventional, Real Life Study on Satisfaction With LNG-IUS in Spanish Young Women (18-30 Years Old) With Different Parity Status and Menstrual Bleeding Pattern
An observational study of Contraception, run by Bayer at 1 site in Spain.
Trial summary
The aim of this non-interventional study (NIS) is to assess, under real-life conditions, woman's satisfaction with Levonogestrel IntraUterine System (LNG-IUS) in a young (18-30 years old (y.o.)) Spanish population taking into account their parity status. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Levonogestrel IntraUterine System (LNG-IUS)
- How many people
- 587 participants
- Where
- 1 siteSpain
- Study dates
- 25 Apr 2018to 15 Mar 2021
- 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 30 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Participants will be women in childbearing age between ≥18 to 30 years, who have freely chosen a LNG-IUS for contraception after being adequately counselled and informed of all contraceptive options by their physician at a routine visit prior to the first study visit (enrolment) in a routine clinical practice setting. Then, women eligible for the enrolment will be visiting the physician in a IUS insertion visit in a gynaecological clinical setting.
Who may be able to join
- Women in childbearing age, between 18-30 years old.
- Women who have chosen a LNG-IUS as contraceptive method, after been adequately counselled by the physician about all contraceptive possible options.
- Women who have chosen a LNG-IUS mainly for contraceptive reasons, not due to heavy menstrual bleeding.
- Women with no desire to conceive for at least within the next 12 months.
- Women capable of reading and writing
Who cannot join
- Women whose main reason to use a LNG-IUS is not a contraceptive reason.
- Women with contraindication for LNG-IUS.
- Women with previous experience with a IUS.
- Women who have been diagnosed with heavy menstrual bleeding.
- Women with degenerative or other kind of diseases that could directly negatively impact their daily life.
- Women who have undergone a hysterectomy or irreversible contraceptive method.
Show all 11Show fewer
- Women participating in a clinical trial.
- Women with a mental illness and unable to make decisions and follow instructions.
- Women with amenorrhea
- Women with clinical history of severe dysmenorrhea
- Women with concomitant medication that may lead changes in bleeding pattern (e.g. antiplatelets and/or anticoagulants)
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this non-interventional study (NIS) is to assess, under real-life conditions, woman's satisfaction with Levonogestrel IntraUterine System (LNG-IUS) in a young (18-30 years old (y.o.)) Spanish population taking into account their parity status.
Furthermore, the study is aimed to evaluate the impact of: menstrual bleeding pattern and satisfaction with it at baseline, LNG-IUS chosen, previously used contraceptive method and reasons for change to/ choice of a LNG-IUS on overall satisfaction with LNG-IUS use.
- Conditions
- Contraception
- Being tested
- Levonogestrel IntraUterine System (LNG-IUS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levonogestrel IntraUterine System (LNG-IUS)Drug
At the routine clinical practice. Jaydess, Mirena, Kyleena Or any other levonogestrel intrauterine system (LNG-IUS) commercialized in Spain at the start of the study, only for contraception indication.
| Study group | Role | What they receive |
|---|---|---|
| Levonogestrel IntraUterine System (LNG-IUS) | Women in childbearing age between 18 to 30 years old and who have freely chosen a LNG-IUS for contraception after being adequately counselled and informed of all contraceptive options by their physician at the routine clinical practice setting in Spain Receives: Drug: Levonogestrel IntraUterine System (LNG-IUS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects rating 1 (very dissatisfied) to 5 (very satisfied) in the 5-point Likert scale overall satisfaction with LNG-IUS
Overall satisfaction with LNG-IUS at end of observation/final visit (i.e. after approximately 12 months or at premature discontinuation). 5 point Likert scale of overall satisfaction with LNG-IUS with end labelling "very dissatisfied" / "very satisfied"
Measured: At approximately 12 months(end of observation/final visit)
Secondary outcomes (12)
Percentage of women rating 1 (very dissatisfied) to 5 (very satisfied) in the 5-point Likert scale of overall satisfaction with the menstrual bleeding profile with LNG-IUS
Overall satisfaction rate with LNG-IUS at end of observation/final visit. 5 point Likert scale of overall satisfaction with the menstrual bleeding pattern with LNG-IUS with end labelling "very dissatisfied" / "very satisfied".
Measured: At 4-12 weeks after insertion, At approximately 12 months(end of observation/final visit)
8 item user satisfaction questionnaire to assess the satisfaction with menstrual bleeding pattern with LNG-IUS
Overall satisfaction with the menstrual bleeding profile with LNG-IUS at end of observation/final visit.
Measured: At approximately 12 months(end of observation/final visit)
Spearman's correlation between overall satisfaction with LNG-IUS and overall satisfaction with menstrual bleeding pattern
Measured: At approximately 12 months(end of observation/final visit)
Percentage of subjects rating 1 (very dissatisfied) to 5 (very satisfied) in the 5-point Likert scale overall satisfaction with LNG-IUS
Overall satisfaction with LNG-IUS 4-12 weeks after insertion. 5 point Likert scale of overall satisfaction with LNG-IUS with end labelling "very dissatisfied" / "very satisfied"
Measured: At 4-12 weeks after insertion
Overall satisfaction with the menstrual bleeding profile 4-12 weeks after insertion.
Measured: At 4-12 weeks after insertion
Ease of LNG-IUS insertion will be measured by investigator on an ordinal scale of "easy", "slightly difficult", "very difficult"
Ease of LNG-IUS insertion assessed by the investigator.
Measured: At initial visit (Day 0_LNG-IUS insertion)
Pain at LNG-IUS insertion will be assessed by the clinician asking to the user on a ordinal scale of "none", "mild", "moderate" or "severe"
Pain at LNG-IUS insertion assessed by the user.
Measured: At initial visit (Day 0_LNG-IUS insertion)
Percentage of women that would recommend a LNG-IUS to peers
Response in recommendation to peers item at final visit.
Measured: At approximately 12 months
Reasons for change to/ choice a LNG-IUS assessed by a multiple choice item
Measured: At initial visit (Day 0_LNG-IUS insertion)
Descriptive analysis of demographic data
Women's profile defined by their sociodemographic and gynaecological characteristics.
Measured: At initial visit (Day 0_LNG-IUS insertion)
Reasons for withdrawal
Measured: Up to approximately 12 months
Percentage of withdrawal
Measured: Up to approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start25 Apr 2018
- Primary completion30 Nov 2020
- Study completion15 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- 587 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03493295
- Sponsor's protocol ID
- 19704
- Acronym
- BERTA
- Status last verified
- Oct 2023
- First submitted
- 4 Apr 2018
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Availability of this study's data will 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.clinicalstudydatarequest.com 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 Study sponsors section of the portal.
Publications
Perello Capo J, Lopez Gonzalez G, Rius-Tarruella J, Calaf Alsina J. Real-world satisfaction and menstrual bleeding pattern with available LNG-IUD among Spanish young women. Eur J Contracept Reprod Health Care. 2022 Dec;27(6):461-472. doi: 10.1080/13625187.2022.2112562. Epub 2022 Sep 23.
PubMed 36148980
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional, Real Life Study on Satisfaction With LNG-IUS in Spanish Young Women (18-30 Years Old) With Different Parity Status and Menstrual Bleeding Pattern
- ClinicalTrials.gov ID
- NCT03493295
- Acronym / sponsor ID
- BERTA / 19704
- Conditions
- Contraception
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 587 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 25 Apr 2018 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 10 Apr 2018 (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.
The aim of this non-interventional study (NIS) is to assess, under real-life conditions, woman's satisfaction with Levonogestrel IntraUterine System (LNG-IUS) in a young (18-30 years old (y.o.)) Spanish population taking into account their parity status.
Furthermore, the study is aimed to evaluate the impact of: menstrual bleeding pattern and satisfaction with it at baseline, LNG-IUS chosen, previously used contraceptive method and reasons for change to/ choice of a LNG-IUS on overall satisfaction with LNG-IUS use.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Levonogestrel IntraUterine System (LNG-IUS) | – | Drug: Levonogestrel IntraUterine System (LNG-IUS)Women in childbearing age between 18 to 30 years old and who have freely chosen a LNG-IUS for contraception after being adequately counselled and informed of all contraceptive options by their physician at the routine clinical practice setting in Spain |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants will be women in childbearing age between ≥18 to 30 years, who have freely chosen a LNG-IUS for contraception after being adequately counselled and informed of all contraceptive options by their physician at a routine visit prior to the first study visit (enrolment) in a routine clinical practice setting. Then, women eligible for the enrolment will be visiting the physician in a IUS insertion visit in a gynaecological clinical setting.
Key inclusion criteria (5 listed)
- Women in childbearing age, between 18-30 years old.
- Women who have chosen a LNG-IUS as contraceptive method, after been adequately counselled by the physician about all contraceptive possible options.
- Women who have chosen a LNG-IUS mainly for contraceptive reasons, not due to heavy menstrual bleeding.
- Women with no desire to conceive for at least within the next 12 months.
- Women capable of reading and writing
Key exclusion criteria (11 listed)
- Women whose main reason to use a LNG-IUS is not a contraceptive reason.
- Women with contraindication for LNG-IUS.
- Women with previous experience with a IUS.
- Women who have been diagnosed with heavy menstrual bleeding.
- Women with degenerative or other kind of diseases that could directly negatively impact their daily life.
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 |
|---|---|---|
| Levonogestrel IntraUterine System (LNG-IUS)At the routine clinical practice. Jaydess, Mirena, Kyleena Or any other levonogestrel intrauterine system (LNG-IUS) commercialized in Spain at the start of the study, only for contraception indication. | Drug | Levonogestrel IntraUterine System (LNG-IUS) |
Primary outcome
Percentage of subjects rating 1 (very dissatisfied) to 5 (very satisfied) in the 5-point Likert scale overall satisfaction with LNG-IUS
Time frame: At approximately 12 months(end of observation/final visit)
Overall satisfaction with LNG-IUS at end of observation/final visit (i.e. after approximately 12 months or at premature discontinuation). 5 point Likert scale of overall satisfaction with LNG-IUS with end labelling "very dissatisfied" / "very satisfied"
12 secondary outcomes
Percentage of women rating 1 (very dissatisfied) to 5 (very satisfied) in the 5-point Likert scale of overall satisfaction with the menstrual bleeding profile with LNG-IUS
Time frame: At 4-12 weeks after insertion, At approximately 12 months(end of observation/final visit)
8 item user satisfaction questionnaire to assess the satisfaction with menstrual bleeding pattern with LNG-IUS
Time frame: At approximately 12 months(end of observation/final visit)
Spearman's correlation between overall satisfaction with LNG-IUS and overall satisfaction with menstrual bleeding pattern
Time frame: At approximately 12 months(end of observation/final visit)
Percentage of subjects rating 1 (very dissatisfied) to 5 (very satisfied) in the 5-point Likert scale overall satisfaction with LNG-IUS
Time frame: At 4-12 weeks after insertion
Overall satisfaction with the menstrual bleeding profile 4-12 weeks after insertion.
Time frame: At 4-12 weeks after insertion
Ease of LNG-IUS insertion will be measured by investigator on an ordinal scale of "easy", "slightly difficult", "very difficult"
Time frame: At initial visit (Day 0_LNG-IUS insertion)
Pain at LNG-IUS insertion will be assessed by the clinician asking to the user on a ordinal scale of "none", "mild", "moderate" or "severe"
Time frame: At initial visit (Day 0_LNG-IUS insertion)
Percentage of women that would recommend a LNG-IUS to peers
Time frame: At approximately 12 months
Reasons for change to/ choice a LNG-IUS assessed by a multiple choice item
Time frame: At initial visit (Day 0_LNG-IUS insertion)
Descriptive analysis of demographic data
Time frame: At initial visit (Day 0_LNG-IUS insertion)
Reasons for withdrawal
Time frame: Up to approximately 12 months
Percentage of withdrawal
Time frame: Up to approximately 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 2 Nov 2023.
- Background: PubMed 36148980Perello Capo J, Lopez Gonzalez G, Rius-Tarruella J, Calaf Alsina J. Real-world satisfaction and menstrual bleeding pattern with available LNG-IUD among Spanish young women. Eur J Contracept Reprod Health Care. 2022 Dec;27(6):461-472. doi: 10.1080/13625187.2022.2112562. Epub 2022 Sep 23.
- Individual participant dataSharing planned: Undecided. Availability of this study's data will 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.clinicalstudydatarequest.com 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 Study sponsors 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 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 5 inclusion and 11 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 2 Nov 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 subjects rating 1 (very dissatisfied) to 5 (very satisfied) in the 5-point Likert scale overall satisfaction with LNG-IUS (time frame: At approximately 12 months(end of observation/final visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03493295, which also lists 1 linked publication.
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 2 Nov 2023.