Contraception
Conditions
Keywords
non-interventional, Mirena, Contraception, Russian Federation
Brief summary
This is local prospective, non-interventional multi-center comparative study. Primary study objective is evaluation of the user satisfaction with Mirena or Copper IUD up to 1 year after insertion ( patient assessment questionnaire) in daily practice. For each patient, the treating gynecologist documents demographics, medical data, safety parameters and treatment signs and symptoms at an initial visit and one or two follow-up visit(s).
Interventions
intrauterine system containing 52 mg levonorgestrel, with daily release of 20 mcg levonorgestrel
DEVICECopper IUD
Copper device, inserted intrauterine
Sponsors
Bayer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Women 20-40 years old * Parity ≥ 1 child * Requesting long-term contraception * Written informed consent.
Exclusion criteria
* in accordance with the current leaflet
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| User satisfaction of the contraception method with Mirena or Copper IUD | up to 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Safety evaluation of Mirena or Copper IUD in routine practice Safety parameters include number of AEs, severity,relationship to Mirena or Cooper IUD | up to 12 months |
| Contraceptive reliability of Mirena or Cooper IUD in routine practice ( fixing number of pregnancies) | up to 12 months |
| Continuation/discontinuation rate ( number of cases with contraceptive method continuation and discontinuations) | up to 12 months |
| Relationship between different parameters and women preferences in choosing Mirena or Cooper IUD as their contraceptive method ( demographic parameters, age group, residence, reproductive history and plans, etc.) using patients questionnaire | up to 12 months |
Countries
Russia
Outcome results
None listed