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Mirena Observational Program

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00883662
First received: April 16, 2009
Last updated: September 29, 2016
Last verified: September 2016
  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 ] [ 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

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: April 16, 2009
Last Updated: September 29, 2016
Health Authority: Kazakhstan: National Center for Expertise of Medicinal Drugs

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

ClinicalTrials.gov processed this record on December 06, 2016