Mirena Efficiency and Tolerability During the First Year of Use

Phase 4

Completed

• Conditions: Medicated Intrauterine Devices; Contraception
• Interventions: Drug: Mirena (BAY86-5028)

• Registration Number: NCT00696202
• Lead Sponsor: Bayer

Brief Summary

In this trial the efficacy and safety of Mirena was investigated during the first year of use

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2003-09
• Study Completion: 2005-03
• Study First Submitted: 2008-06-10
• Study First Submitted QC: 2008-06-11
• Study First Posted: 2008-06-12
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-30
• Last Update Posted: 2014-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 199

Inclusion Criteria

• Women aged 25 to 39 years who sought effective contraception during the post-partum period (i.e. insertion of the device between 6 and 12 weeks after parturition).

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Exclusion Criteria

• Standard exclusion criteria for use of intrauterine hormone devices

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Mirena (BAY86-5028)	-

Primary Outcome Measures

Name	Time	Method
Adverse event related to the product causing a subject to withdraw, or be withdrawn, from the study at any time up to 12 months from the insertion of Mirena	within 12 months after randomization

Secondary Outcome Measures

Name	Time	Method
General safety assessment	within 12 months after randomization