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Mirena Efficiency and Tolerability During the First Year of Use

NCT ID: NCT00696202

Last Updated: 2014-12-31

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

Clinical Phase

PHASE4

Total Enrollment

199 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2005-03-31

Brief Summary

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

Detailed Description

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Conditions

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Medicated Intrauterine Devices Contraception

Keywords

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Mirena Levonorgestrel Intrauterine device Efficacy Tolerability First year of use

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Mirena (BAY86-5028)

Intervention Type DRUG

Intrauterine levonorgestrel containing device (market product)

Interventions

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Mirena (BAY86-5028)

Intrauterine levonorgestrel containing device (market product)

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

25 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

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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Amiens, , France

Site Status

Countries

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France

Other Identifiers

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307702

Identifier Type: -

Identifier Source: secondary_id

91295

Identifier Type: -

Identifier Source: org_study_id