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Mirena Observational Program

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00883662
First received: April 16, 2009
Last updated: November 3, 2014
Last verified: November 2014
  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: 187
Study Start Date: June 2009
Estimated Study Completion Date: December 2014
Primary Completion Date: January 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
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:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00883662     History of Changes
Other Study ID Numbers: 14474, MA0910KZ
Study First Received: April 16, 2009
Last Updated: November 3, 2014
Health Authority: Kazakhstan: National Center for Expertise of Medicinal Drugs

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

ClinicalTrials.gov processed this record on November 23, 2014