Contraception
Conditions
Brief summary
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.
Interventions
DRUGLevonorgestrel- Intra Uterine System (BAY 86-5028_Mirena)
Levonorgestrel 52 mg intrauterine system with release rate of upto 20 mcg/day, Intrauterine insertion
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
No
Inclusion criteria
* Subject aged between 18-49 years who are initiating LNG IUS therapy for contraception. * Subject willing to provide informed consent and comply with study procedure.
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage continuation rate of LNG IUS at end of observation period. | 12 months |
| Percentage of Women with user satisfaction scoring somewhat satisfied to very satisfied | 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative discontinuation rate for pregnancy | 12 months | — |
| Cumulative discontinuation rate for other medical reasons | 12 months | — |
| Mean percentage of women with amenorrhea | 12 months | — |
| Distribution of contraceptive usage patterns | 12 months | 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 |
| Incidence rate of drug-related adverse events | 12 months | — |
| Cumulative discontinuation rate for non-medical reasons | 12 months | — |
| Mean percent of women with spotting, inter-menstrual bleeding | 12 months | — |
Countries
India
Outcome results
None listed