check_circleStudy Completed

Contraception, Menorrhagia, Endometrial Hyperplasia, Estrogen replacement therapy

Bayer Identifier:

14474

ClinicalTrials.gov Identifier:

NCT00883662

EudraCT Number:

Not Available

EU CT Number:

Not Available
Mirena observational program

Trial purpose

Mirena is used for long-term in Kazakhstan, and in our observational program we would like to study patients distribution per indications of Mirena, and also patient compliance within a year after Mirena insertion. For patients with all approved indications for Mirena use: contraception, treatment of menorrhagia and protection from endometrial hyperplasia during estrogen replacement therapy

Key Participants Requirements

Sex

Female

Age

18 - N/A
  • - Patients older than 18 years with previously taken decision of their gynecologist to insert Mirena according to registered indications
  • - All patients with contraindications to Mirena insertion, according to approved prescribing information.

Trial summary

Enrollment Goal
2725
Trial Dates
May 2009 - November 2015
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, Kazakhstan

Primary Outcome

  • Patient distribution per indication
    date_rangeTime Frame:
    12 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Patient compliance
    date_rangeTime Frame:
    12 months
    enhanced_encryption
    Safety Issue:
    No

Trial design

Mirena observational program
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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