check_circleStudy Completed
Contraception
Bayer Identifier:
19704
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial purpose
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.
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.
Key Participants Requirements
Sex
FemaleAge
18 - 30 YearsTrial summary
Enrollment Goal
587Trial Dates
April 2018 - March 2021Phase
Phase 4Could I Receive a placebo
NoProducts
Skyla (Levonorgestrel, BAY86-5028)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many locations | Many locations, Spain |
Primary Outcome
- Percentage of subjects rating 1 (very dissatisfied) to 5 (very satisfied) in the 5-point Likert scale overall satisfaction with LNG-IUSOverall 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”date_rangeTime Frame:At approximately 12 months(end of observation/final visit)
Secondary Outcome
- 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-IUSOverall 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”.date_rangeTime 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-IUSOverall satisfaction with the menstrual bleeding profile with LNG-IUS at end of observation/final visit.date_rangeTime 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 patterndate_rangeTime 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-IUSOverall 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”date_rangeTime Frame:At 4-12 weeks after insertion
- Overall satisfaction with the menstrual bleeding profile 4-12 weeks after insertion.date_rangeTime 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.date_rangeTime 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.date_rangeTime Frame:At initial visit (Day 0_LNG-IUS insertion)
- Percentage of women that would recommend a LNG-IUS to peersResponse in recommendation to peers item at final visit.date_rangeTime Frame:At approximately 12 months
- Reasons for change to/ choice a LNG-IUS assessed by a multiple choice itemdate_rangeTime Frame:At initial visit (Day 0_LNG-IUS insertion)
- Descriptive analysis of demographic dataWomen’s profile defined by their sociodemographic and gynaecological characteristics.date_rangeTime Frame:At initial visit (Day 0_LNG-IUS insertion)
- Reasons for withdrawaldate_rangeTime Frame:Up to approximately 12 months
- Percentage of withdrawaldate_rangeTime Frame:Up to approximately 12 months
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A