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:

NCT03493295

EudraCT Number:

Not Available

Study Completed

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
587
Trial Dates
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Phase
4
Could I receive a placebo?
No
Products
Skyla (Levonorgestrel, BAY86-5028)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Many locations

Many locations, Spain

Status
Completed
 

Trial Design