The Aim of This Study is to Estimate the Discontinuation Rate of Low-dose Levonorgestrel-releasing Intrauterine System Due to Self-reported Unacceptable Menstrual Bleeding Pattern in Spanish Women Who Are Using it for the First Time How Intrauterine System for Long Acting Contraception
Condition: Hormonal Intrauterine Contraception
MeSH terms: Hemorrhage
Study type: Observational

Summary: 
      Researchers are looking for better ways to help women prevent pregnancy. Every month, a
      woman's body prepares for pregnancy in a process called the menstrual cycle. When pregnancy
      does not happen, menstruation occurs. During menstruation, women lose blood and tissue from
      inside the womb. This bleeding can last for about 2 to 7 days.

      Hormonal intrauterine contraception aims to help women prevent pregnancy by stopping the
      process of the menstrual cycle. Intrauterine means that the contraception is in the form of a
      device that is inserted into a woman's womb by her doctor. The device then releases the
      contraception into the womb.

      Researchers have found that when women use hormonal contraception, the disruption to the
      menstrual cycle can cause changes to how often and for how long women will bleed. So, the
      researchers in this study want to learn more about the menstrual bleeding patterns of women
      in Spain who are using hormonal intrauterine contraception for the first time. In other
      words, In particular for the LNG-IUSs, irregular bleeding due to the local effect of
      levonorgestrel on the endometrium is common, particularly during the first 3 months of use,
      and it is of interest to know if this is a major reason why Spanish women discontinue this
      very effective method and what other factors may be associated with discontinuation. The
      researchers will then use this information to estimate how many women choose to stop using
      the contraception. The participants will be able to enroll in this study after requesting
      hormonal intrauterine contraception from their doctor. They will be women between the ages of
      18 and 35 who have never used hormonal intrauterine contraception before.

      The participants will visit the study site 3 times. On the first visit, they will receive the
      hormonal intrauterine contraception. The doctors will also check their health to make sure
      they can join the study. The participants will visit the study site again 4-12 weeks later,
      and one last time after 1 year of having the hormonal intrauterine contraception. During
      these visits, the doctors will ask the participants questions about any medical problems they
      have and if they want to continue using the contraception. Throughout the study, the
      participants will use a mobile app to track information about their menstrual bleeding and
      how they feel about it.
    


Intervention name(s): Low-dose levonorgestrel intrauterine systems (LNG-IUS)
Intervention type(s): Drug
Intervention description(s): Any low-dose intrauterine system (IUS) marketed in Spain
Intervention MeSH terms: Levonorgestrel
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Young adult women from Spain
      
Keywords: Intrauterine system (IUS); Levonorgestrel (LNG); Menstrual bleeding; Discontinuation of intrauterine systems