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Mirena Efficiency and Tolerability During the First Year of Use
This study has been completed.
Sponsored by: Bayer
Information provided by: Bayer
ClinicalTrials.gov Identifier: NCT00696202
  Purpose

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


Condition Intervention Phase
Contraception
 Drug: Mirena
 Phase IV

Drug Information available for: Levonorgestrel
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: A Multicentre, Open Label, Uncontrolled Study of the Tolerance, Acceptability and Contraceptive Efficacy of Mirena 52 mg®, an Intra-Uterine Levonorgestrel Device, During the First Year After Insertion Post-Partum

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Adverse event related to the product causing a subject to withdraw, or be withdrawn, from the study at any time up to 12 months from the insertion of Mirena [ Time Frame: within 12 months after randomization ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • General safety assessment [ Time Frame: within 12 months after randomization ] [ Designated as safety issue: Yes ]

Enrollment: 150
Study Start Date: September 2003
Study Completion Date: April 2005
Arms Assigned Interventions
Arm 1: Experimental
n/a
Drug: Mirena
Intrauterine levonorgestrel containing device (market product)

  Eligibility

Ages Eligible for Study:   25 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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).

Exclusion Criteria:

  • Standard exclusion criteria for use of intrauterine hormone devices.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00696202

Locations
France
Amiens Cedex 01, France, 80054
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

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Responsible Party: ( Bayer Schering Pharma AG, Therapeutic Area Head )
Study ID Numbers: 91295, 307702
Study First Received: June 10, 2008
Last Updated: June 11, 2008
ClinicalTrials.gov Identifier: NCT00696202  
Health Authority: France: Ministry of Health;   United States: Institutional Review Board

Keywords provided by Bayer:
Mirena
Levonorgestrel
Intrauterine device
Efficacy
 Tolerability
First year of use
Medicated Intrauterine Devices

Study placed in the following topic categories:
Levonorgestrel

Additional relevant MeSH terms:
Contraceptive Agents
Therapeutic Uses
Contraceptives, Oral
Physiological Effects of Drugs
 Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Reproductive Control Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009



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