The study is designed as non interventional to observe the continuation rate and the patient satisfaction in women who have a LNG-IUS (Levonorgestrel releasing Intrauterine system) inserted for contraception over the period of 12 months under real life condition in India.The study will begin after the study approval by ethics committee.All Indian women aged between 18-49 years who are initiating LNG IUS therapy for contraception will be included in study after taking the informed consent.Patients will be observed for upto 12 months.The study involves general examination of patients, collection of data like medical history, previous contraceptive use,concomitant medication etc.The study is planned to enroll 600 subjects from multiple study centers spread across India. The study data will be analyzed with appropriate statistical methods.
Study Type
OBSERVATIONAL
Enrollment
600
Levonorgestrel 52 mg intrauterine system with release rate of upto 20 mcg/day, Intrauterine insertion
Unnamed facility
Multiple Locations, India
Percentage continuation rate of LNG IUS at end of observation period.
Time frame: 12 months
Percentage of Women with user satisfaction scoring somewhat satisfied to very satisfied
Time frame: 12 months
Cumulative discontinuation rate for pregnancy
Time frame: 12 months
Cumulative discontinuation rate for other medical reasons
Time frame: 12 months
Cumulative discontinuation rate for non-medical reasons
Time frame: 12 months
Mean percentage of women with amenorrhea
Time frame: 12 months
Mean percent of women with spotting, inter-menstrual bleeding
Time frame: 12 months
Distribution of contraceptive usage patterns
contraceptive usage patterns included:birth-spacing, long term contraception, postpartum contraception, post-abortion contraception, switch from other method, contraception for other medical reasons like heart disease, etc
Time frame: 12 months
Incidence rate of drug-related adverse events
Time frame: 12 months
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