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 (CORA)

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.

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 Overview

• Status: Completed
• Conditions: Hormonal Intrauterine Contraception
• Intervention / Treatment: Drug: Low-dose levonorgestrel intrauterine systems (LNG-IUS)

• Study Type: Observational
• Enrollment (Actual): 316

Contacts and Locations

Study Locations

• Spain
  • Multiple Locations, Spain
    • Many Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Young adult women from Spain

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Drug: Low-dose levonorgestrel intrauterine systems (LNG-IUS); Any low-dose intrauterine system (IUS) marketed in Spain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of women who discontinue the use of low-dose LNG-IUS due to the unacceptability of their menstrual bleeding pattern	Up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of women who discontinued lowdose LNG-IUS due to other reasons		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	At final visit (up to 12 months)
Potential correlation of women's perception on pre-insertion counselling with overall satisfaction with menstrual bleeding pattern		At final visit (up to 12 months)
Usage of the mobile apps to support menstrual tracking (regularly, sporadically, never)		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)		At initial visit, follow-up and final visit (up to 12 months)
Correlation between the use of a menstrual app and discontinuation		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		At initial visit, follow-up and final visit (up to 12 months)
Size of uterine cavity		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	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	Up to 12 months
Correlation between uterine cavity size and menstrual bleeding pattern		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)		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		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		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		At final visit (up to 12 months)
Days up to discontinuation day		at the follow-up visit and at the final visit (up to 12 months)

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2021
• Primary Completion (Actual): January 12, 2023
• Study Completion (Actual): May 4, 2023

Study Registration Dates

• First Submitted: February 4, 2021
• First Submitted That Met QC Criteria: March 3, 2021
• First Posted (Actual): March 8, 2021

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 13, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Intrauterine system (IUS); Levonorgestrel (LNG); Menstrual bleeding; Discontinuation of intrauterine systems
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Physiological Effects of Drugs; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Levonorgestrel
• Other Study ID Numbers: 21279

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No