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

Status: Completed

Conditions: Contraception

Treatments: Drug: Levonogestrel IntraUterine System (LNG-IUS)

Study type: Observational

Funder types: Industry

Identifiers

NCT03493295

19704

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)