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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

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

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

Study Type : Observational
Actual Enrollment : 2725 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mirena Observational Program
Study Start Date : May 2009
Actual Primary Completion Date : April 2014
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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



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

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

Biospecimen Retention:   None Retained
n.a


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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.

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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00883662     History of Changes
Other Study ID Numbers: 14474
MA0910KZ ( Other Identifier: company internal )
First Posted: April 20, 2009    Key Record Dates
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