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Mirena Observational Program

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Contraception; Menorrhagia; Endometrial Hyperplasia; Estrogen Replacement Therapy

Intervention: Levonorgestrel (Mirena, BAY86-5028) (Drug)

Phase: N/A

Status: Active, not recruiting

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

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

Clinical Details

Official title: Mirena Observational Program

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Patient distribution per indication

Secondary outcome: Patient compliance

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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.

Locations and Contacts

Many Locations, Kazakhstan
Additional Information

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Starting date: June 2009
Last updated: August 18, 2015

Page last updated: August 23, 2015

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