Non-interventional Study of Long-term Intrauterine Contraceptives Acceptability and User Satisfaction
Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Contraception
Intervention: Levonorgestrel (Mirena, BAY86-5028) (Drug); Copper IUD (Device)
Phase: N/A
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s): Bayer Study Director, Study Director, Affiliation: Bayer
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).
Clinical Details
Official title: Prospective Multicentre Non-interventional Comparative Study of Long-term Intrauterine Contraceptives Acceptability and User Satisfaction
Study design: Observational Model: Case-Only, Time Perspective: Prospective
Primary outcome: User satisfaction of the contraception method with Mirena or Copper IUD
Secondary outcome: Safety evaluation of Mirena or Copper IUD in routine practice Safety parameters include number of AEs, severity,relationship to Mirena or Cooper IUDContraceptive reliability of Mirena or Cooper IUD in routine practice ( fixing number of pregnancies) Continuation/discontinuation rate ( number of cases with contraceptive method continuation and discontinuations) 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
Eligibility
Minimum age: 20 Years.
Maximum age: 40 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Many Locations, Russian Federation
Additional Information
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Starting date: September 2011
Last updated: November 10, 2014
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