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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)

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Bayer

Status

Completed

Conditions

Contraception

Treatments

Drug: Levonogestrel IntraUterine System (LNG-IUS)

Study type

Observational

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Enrollment

587 patients

Sex

Female

Ages

18 to 30 years old

Volunteers

Accepts Healthy Volunteers

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 design

587 participants in 1 patient group

Levonogestrel IntraUterine System (LNG-IUS)
Description:
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
Treatment:
Drug: Levonogestrel IntraUterine System (LNG-IUS)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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