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Mirena Observational Program

This study is currently recruiting participants.
Verified May 2013 by Bayer
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00883662
First received: April 16, 2009
Last updated: May 6, 2013
Last verified: May 2013
History of Changes
  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:

MedlinePlus related topics: Birth Control
U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Patient distribution per indication [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient compliance [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

n.a


Estimated Enrollment: 7500
Study Start Date: June 2009
Estimated Study Completion Date: July 2014
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00883662

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

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

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Medical Director, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT00883662     History of Changes
Other Study ID Numbers: 14474, MA0910KZ
Study First Received: April 16, 2009
Last Updated: May 6, 2013
Health Authority: Kazakhstan: National Center for Expertise of Medicinal Drugs

Additional relevant MeSH terms:
Endometrial Hyperplasia
Hyperplasia
Menorrhagia
Adenoma
Uterine Diseases
Genital Diseases, Female
Pathologic Processes
Uterine Hemorrhage
Menstruation Disturbances
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Levonorgestrel
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Oral, Synthetic
Contraceptives, Oral

ClinicalTrials.gov processed this record on May 19, 2013