check_circleStudy Completed

Contraception

Bayer Identifier:

19704

ClinicalTrials.gov Identifier:

NCT03493295

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.

Key Participants Requirements

Sex

Female

Age

18 - 30 Years
  • -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


  • -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.
    -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 summary

Enrollment Goal
587
Trial Dates
April 2018 - March 2021
Phase
Phase 4
Could I Receive a placebo
No
Products
Skyla (Levonorgestrel, BAY86-5028)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Many locationsMany 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-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”
    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-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”.
    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-IUS
    Overall 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 pattern
    date_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-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”
    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 peers
    Response 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 item
    date_rangeTime Frame:
    At initial visit (Day 0_LNG-IUS insertion)
  • Descriptive analysis of demographic data
    Women’s profile defined by their sociodemographic and gynaecological characteristics.
    date_rangeTime Frame:
    At initial visit (Day 0_LNG-IUS insertion)
  • Reasons for withdrawal
    date_rangeTime Frame:
    Up to approximately 12 months
  • Percentage of withdrawal
    date_rangeTime Frame:
    Up to approximately 12 months

Trial design

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 Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

Click here to find results for studies related to Bayer products.