Mirena Observational Program

Completed

• Conditions: Contraception; Endometrial Hyperplasia; Estrogen Replacement Therapy; Menorrhagia
• Interventions: Drug: Levonorgestrel (Mirena, BAY86-5028)

• Registration Number: NCT00883662
• Lead Sponsor: Bayer

Brief 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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2009-04-16
• Study First Submitted QC: 2009-04-17
• Study First Posted: 2009-04-20
• Study Start: 2009-05
• Primary Completion: 2014-04
• Study Completion: 2015-11
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-29
• Last Update Posted: 2016-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2725

Inclusion Criteria

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

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Exclusion Criteria

• All patients with contraindications to Mirena insertion, according to approved prescribing information.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Levonorgestrel (Mirena, BAY86-5028)	-

Primary Outcome Measures

Name	Time	Method
Patient distribution per indication	12 months

Secondary Outcome Measures

Name	Time	Method
Patient compliance	12 months