Trial Condition(s):
Contraception
Non-interventional study of long-term intrauterine contraceptives acceptability and user satisfaction (Mirabel)
Bayer Identifier:
15508
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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).
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Many Locations, Russia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Prospective multicentre non-interventional comparative study of long-term intrauterine contraceptives acceptability and user satisfaction
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
2
Primary Outcome
- User satisfaction of the contraception method with Mirena or Copper IUDTimeframe: up to 12 months
Secondary Outcome
- Safety evaluation of Mirena or Copper IUD in routine practice Safety parameters include number of AEs, severity,relationship to Mirena or Cooper IUDTimeframe: up to 12 months
- Contraceptive reliability of Mirena or Cooper IUD in routine practice ( fixing number of pregnancies)Timeframe: up to 12 months
- Continuation/discontinuation rate ( number of cases with contraceptive method continuation and discontinuations)Timeframe: 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 questionnaireTimeframe: up to 12 months
Additional Information
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