An observational study in Contraception, sponsored by Bayer. Completed at 1 site in Spain. Open to female participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-02.
Sponsored by Bayer · Observational
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.
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.
Exclusion Criteria:
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
Drug: 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.
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"
Time frame: At approximately 12 months(end of observation/final visit)
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".
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
Overall satisfaction with the menstrual bleeding profile with LNG-IUS at end of observation/final visit.
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
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"
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"
Ease of LNG-IUS insertion assessed by the investigator.
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"
Pain at LNG-IUS insertion assessed by the user.
Time frame: 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.
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
Women's profile defined by their sociodemographic and gynaecological characteristics.
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
Plan to share: 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.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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