Mirena Efficiency and Tolerability During the First Year of Use

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00696202
First received: June 10, 2008
Last updated: October 10, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention Phase
Medicated Intrauterine Devices
Contraception
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  • Adverse event related to the product causing a subject to withdraw, or be withdrawn, from the study at any time up to 12 months from the insertion of Mirena [ Time Frame: within 12 months after randomization ] [ Designated as safety issue: Yes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: 150
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)

  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

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00696202     History of Changes
Other Study ID Numbers: 91295, 307702
Study First Received: June 10, 2008
Last Updated: October 10, 2013
Health Authority: France: Ministry of Health

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

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

ClinicalTrials.gov processed this record on April 14, 2014