An observational study in Contraception, sponsored by Bayer. Completed at 1 site in Russian Federation. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2015-10-16.
Sponsored by Bayer · Observational
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).
Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
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Females who plan long-term contraception and meet criteria of inclusion and exclusion.
Exclusion Criteria:
Drug: Levonorgestrel (Mirena, BAY86-5028)
Device: Copper IUD
intrauterine system containing 52 mg levonorgestrel, with daily release of 20 mcg levonorgestrel
Copper device, inserted intrauterine
User satisfaction of the contraception method with Mirena or Copper IUD
Time frame: up to 12 months
Safety evaluation of Mirena or Copper IUD in routine practice Safety parameters include number of AEs, severity,relationship to Mirena or Cooper IUD
Time frame: up to 12 months
Contraceptive reliability of Mirena or Cooper IUD in routine practice ( fixing number of pregnancies)
Time frame: up to 12 months
Continuation/discontinuation rate ( number of cases with contraceptive method continuation and discontinuations)
Time frame: 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
Time frame: up to 12 months
This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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