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| ID | Type | Description | Link |
|---|---|---|---|
| MA1010RU | Other Identifier | company internal |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 |
| ||
| Group 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levonorgestrel (Mirena, BAY86-5028) | Drug | intrauterine system containing 52 mg levonorgestrel, with daily release of 20 mcg levonorgestrel |
|
| Measure | Description | Time Frame |
|---|---|---|
| User satisfaction of the contraception method with Mirena or Copper IUD | up to 12 months |
| Measure | Description | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Females who plan long-term contraception and meet criteria of inclusion and exclusion.
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | Russia |
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| ID | Term |
|---|---|
| D016912 | Levonorgestrel |
| D007435 | Intrauterine Devices, Copper |
| ID | Term |
|---|---|
| D009644 | Norgestrel |
| D009652 | Norpregnenes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 |
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| Copper IUD | Device | Copper device, inserted intrauterine |
|
| 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 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D007436 | Intrauterine Devices, Medicated |
| D007434 | Intrauterine Devices |
| D003274 | Contraceptive Devices, Female |
| D003273 | Contraceptive Devices |
| D004864 | Equipment and Supplies |