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Mirena Observational Program

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00883662
First Posted: April 20, 2009
Last Update Posted: September 30, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
  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

Condition Intervention
Contraception Menorrhagia Endometrial Hyperplasia Estrogen Replacement Therapy Drug: Levonorgestrel (Mirena, BAY86-5028)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mirena Observational Program

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Patient distribution per indication [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Patient compliance [ Time Frame: 12 months ]

Biospecimen Retention:   None Retained
n.a

Enrollment: 2725
Study Start Date: May 2009
Study Completion Date: November 2015
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Levonorgestrel (Mirena, BAY86-5028)
Patients older than 18 years with previously taken decision of their gynecologist to insert Mirena according to registered indications

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00883662


Locations
Kazakhstan
Many Locations, Kazakhstan
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00883662     History of Changes
Other Study ID Numbers: 14474
MA0910KZ ( Other Identifier: company internal )
First Submitted: April 16, 2009
First Posted: April 20, 2009
Last Update Posted: September 30, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Hyperplasia
Menorrhagia
Endometrial Hyperplasia
Pathologic Processes
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Menstruation Disturbances
Levonorgestrel
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral