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Mirena Observational Program

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ClinicalTrials.gov Identifier: NCT00883662
Recruitment Status : Completed
First Posted : April 20, 2009
Last Update Posted : September 30, 2016
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date April 16, 2009
First Posted Date April 20, 2009
Last Update Posted Date September 30, 2016
Study Start Date May 2009
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 17, 2009)
Patient distribution per indication [ Time Frame: 12 months ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT00883662 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 17, 2009)
Patient compliance [ Time Frame: 12 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Mirena Observational Program
Official Title Mirena Observational Program
Brief Summary 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
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   None Retained
Description:
n.a
Sampling Method Non-Probability Sample
Study Population Patients older than 18 years with previously taken decision of their gynecologist to insert Mirena according to registered indications
Condition
  • Contraception
  • Menorrhagia
  • Endometrial Hyperplasia
  • Estrogen Replacement Therapy
Intervention Drug: Levonorgestrel (Mirena, BAY86-5028)
Patients older than 18 years with previously taken decision of their gynecologist to insert Mirena according to registered indications
Study Groups/Cohorts Group 1
Intervention: Drug: Levonorgestrel (Mirena, BAY86-5028)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 29, 2016)
2725
Original Estimated Enrollment
 (submitted: April 17, 2009)
7500
Actual Study Completion Date November 2015
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients older than 18 years with previously taken decision of their gynecologist to insert Mirena according to registered indications

Exclusion Criteria:

  • All patients with contraindications to Mirena insertion, according to approved prescribing information.
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Kazakhstan
Removed Location Countries  
 
Administrative Information
NCT Number NCT00883662
Other Study ID Numbers 14474
MA0910KZ ( Other Identifier: company internal )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Bayer
Study Sponsor Bayer
Collaborators Not Provided
Investigators
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date September 2016