Trial Condition(s):
Contraception
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 (BERTA)
Bayer Identifier:
19704
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
Inclusion Criteria
-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
Exclusion Criteria
-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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Many locations Many locations, Spain | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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:
1
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”Timeframe: 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”.Timeframe: 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.Timeframe: At approximately 12 months(end of observation/final visit)
- Spearman’s correlation between overall satisfaction with LNG-IUS and overall satisfaction with menstrual bleeding patternTimeframe: 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”Timeframe: At 4-12 weeks after insertion
- Overall satisfaction with the menstrual bleeding profile 4-12 weeks after insertion.Timeframe: 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.Timeframe: 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.Timeframe: 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.Timeframe: At approximately 12 months
- Reasons for change to/ choice a LNG-IUS assessed by a multiple choice itemTimeframe: At initial visit (Day 0_LNG-IUS insertion)
- Descriptive analysis of demographic dataWomen’s profile defined by their sociodemographic and gynaecological characteristics.Timeframe: At initial visit (Day 0_LNG-IUS insertion)
- Reasons for withdrawalTimeframe: Up to approximately 12 months
- Percentage of withdrawalTimeframe: Up to approximately 12 months
Additional Information
Copyright © Bayer
Powered by
