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  • Adverse event related to the product causing a subject to withdraw, or be withdrawn, from the study at any time up to 12 months from the insertion of Mirena [ Time Frame: within 12 months after randomization ] [ Designated as safety issue: Yes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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 31, 2014