check_circleStudy Completed

Contraception

Bayer Identifier:

15508

ClinicalTrials.gov Identifier:

NCT01590537

EudraCT Number:

Not Available

EU CT Number:

Not Available
Non-interventional study of long-term intrauterine contraceptives acceptability and user satisfaction

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).

Key Participants Requirements

Sex

Female

Age

20 - 40 Years
  • - Women 20-40 years old
    - Parity ≥ 1 child
    - Requesting long-term contraception
    - Written informed consent.
  • - in accordance with the current leaflet

Trial summary

Enrollment Goal
2348
Trial Dates
September 2011 - October 2014
Phase
N/A
Could I Receive a placebo
No
Products
Mirena (Levonorgestrel IUS, BAY86-5028)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Russia

Primary Outcome

  • User satisfaction of the contraception method with Mirena or Copper IUD
    date_rangeTime Frame:
    up to 12 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Safety evaluation of Mirena or Copper IUD in routine practice Safety parameters include number of AEs, severity,relationship to Mirena or Cooper IUD
    date_rangeTime Frame:
    up to 12 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Contraceptive reliability of Mirena or Cooper IUD in routine practice ( fixing number of pregnancies)
    date_rangeTime Frame:
    up to 12 months
    enhanced_encryption
    Safety Issue:
    No
  • Continuation/discontinuation rate ( number of cases with contraceptive method continuation and discontinuations)
    date_rangeTime Frame:
    up to 12 months
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    up to 12 months
    enhanced_encryption
    Safety Issue:
    No

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
N/A

Additional Information

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