Mirena Efficiency and Tolerability During the First Year of Use

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: June 10, 2008
Last updated: December 30, 2014
Last verified: December 2014
In this trial the efficacy and safety of Mirena was investigated during the first year of use

Condition Intervention Phase
Medicated Intrauterine Devices
Drug: Mirena (BAY86-5028)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

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  • Adverse event related to the product causing a subject to withdraw, or be withdrawn, from the study at any time up to 12 months from the insertion of Mirena [ Time Frame: within 12 months after randomization ] [ Designated as safety issue: Yes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: 199
Study Start Date: September 2003
Study Completion Date: March 2005
Arms Assigned Interventions
Experimental: Arm 1 Drug: Mirena (BAY86-5028)
Intrauterine levonorgestrel containing device (market product)


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

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00696202

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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00696202     History of Changes
Other Study ID Numbers: 91295  307702 
Study First Received: June 10, 2008
Last Updated: December 30, 2014
Health Authority: France: Ministry of Health

Keywords provided by Bayer:
Intrauterine device
First year of use

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

ClinicalTrials.gov processed this record on May 30, 2016