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Mirena Observational Program

NCT ID: NCT00883662

Last Updated: 2016-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2725 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-05-31

Study Completion Date

2015-11-30

Brief Summary

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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

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Detailed Description

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Conditions

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Contraception Menorrhagia Endometrial Hyperplasia Estrogen Replacement Therapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Levonorgestrel (Mirena, BAY86-5028)

Intervention Type DRUG

Patients older than 18 years with previously taken decision of their gynecologist to insert Mirena according to registered indications

Interventions

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Levonorgestrel (Mirena, BAY86-5028)

Patients older than 18 years with previously taken decision of their gynecologist to insert Mirena according to registered indications

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Many Locations, , Kazakhstan

Site Status

Countries

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Kazakhstan

Other Identifiers

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MA0910KZ

Identifier Type: OTHER

Identifier Source: secondary_id

14474

Identifier Type: -

Identifier Source: org_study_id

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